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Lung Cancer Trials

NCI-2020-00751

A081801: Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO

The ALCHEMIST trial focuses on adding immunotherapy to the treatment plan for non-small cell lung cancer (NSCLC) patients who have had surgery to remove their tumors. This trial, known as "Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO," aims to see if combining immunotherapy with standard chemotherapy after surgery is more effective than the usual treatment. Researchers also want to identify any markers in patients' bodies that could predict how well they respond to immunotherapy. Ultimately, the trial aims to improve treatment strategies for NSCLC patients after surgery by better understanding the role of immunotherapy.

Resected:

Some patients have a tumor that is “resectable,” which means that it is able to be removed with surgery.

Immunotherapy:

The immune system helps fight cancer by sending the body's defense (immune) system to kill the cancer cells. Immunotherapy drugs target cancer cells to prevent them from multiplying and growing.

Therapy given after surgery for cancer

Adjuvant therapy:

Site:

Einstein

NCT Number:

NCI-2021-06578

A Phase 2 Trial of Adagrasib Monotherapy and in Combination with Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab plusChemotherapy in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation

There are two medical studies happening in this phase 2 trial. One is looking at a drug called Adagrasib by itself and with another immunotherapy drug called Pembrolizumab to see if they work for a variety of unresectable or metastatic non-small cell lung cancers. The other study compares Adagrasib with Pembrolizumab to Pembrolizumab with chemotherapy to see which treatment works better for this specific type of lung cancer. These studies aim to find better treatments for lung cancer patients with a certain genetic mutation called KRAS G12 C.

Metastatic:

Cancer that has spread from its original location or organ to other parts of the body

Phase 2:

An advanced point of testing, where they're trying to confirm if a treatment works well.

Immunotherapy:

The immune system helps fight cancer by sending the body's defense (immune) system to kill the cancer cells. Immunotherapy drugs target cancer cells to prevent them from multiplying and growing.

Unresectable:

Unable to be removed through surgery

Metastatic:

cancer that has spread from its original location or organ to other parts of the body.

NSCLC:

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Mutation:

Mutation is an alteration in the genetic material of a cell or a virus that can be inherited by its descendants

Site:

Einstein

NCT Number:

NCI-2021-11191

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of FWD1509 MsOH in Advanced Non-Small Cell Lung Cancer

This study is about testing a new treatment called FWD1509 MsOH for advanced non-small cell lung cancer. The study is looking at how safe and tolerable the treatment is, how the body processes it (pharmacokinetics), and how well it works against tumors. It is an open-label, Phase 1/2 study. The goal is to see if this new treatment can help patients with advanced lung cancer.

Phase 1/2:

Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.

Pharmacokinectics:

Pharmacokinetics studies how medicines move around in the body, including how they are absorbed, distributed, broken down, and removed.

NSCLC:

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Open-Label:

Patients know which treatments are being given to them

Site:

Einstein

NCT Number:

NCI-2019-07941

Randomized Phase III Study of Combination AZD9291 (Osimertinib) and Bevacizumab Versus AZD9291 (Osimertinib) Alone as First-Line Treatment for Patients with Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)

This randomized study is about comparing two treatments for a type of lung cancer called non-small cell lung cancer (NSCLC). One treatment is a combination of two drugs: AZD9291 (also known as Osimertinib) and Bevacizumab. The other treatment is just AZD9291 alone. The study wants to see which treatment works better as the first treatment for patients with NSCLC that has spread to other parts of the body. The goal is to find the most effective treatment for this type of lung cancer with an EGFR mutation.

Randomized:

Patients are randomly assigned to one of two groups. It's like flipping a coin to decide who gets which treatment

Epidermal growth factor receptor:

Epidermal Growth Factor Receptor (EGFR) is on the surface of cells and helps them grow and divide. In cancer, EGFR is like a switch that gets stuck in the "on" position, making cells grow and divide too much.

Mutation:

Mutation is an alteration in the genetic material of a cell or a virus that can be inherited by its descendants

NSCLC:

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Site:

Einstein/Sinai

NCT Number:

NCI-2023-00768

An open label, randomized study of neoadjuvant nivolumab and chemotherapy, with or without sub-ablative stereotactic body radiation therapy, for resectable stage IIA to IIIB non-small cell lung cancer

Stereotactic body radiation therapy:

A treatment method delivers strong and precise doses of radiation to cancerous tumors, aiming to get rid of cancer cells while sparing nearby healthy tissue from harm.

Immunotherapy:

The immune system helps fight cancer by sending the body's defense (immune) system to kill the cancer cells. Immunotherapy drugs target cancer cells to prevent them from multiplying and growing.

Resectable:

Some patients have a tumor that is “resectable,” which means that it is able to be removed with surgery.

Open-Label:

Patients know which treatments are being given to them

NSCLC:

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Randomized:

Patients are randomly assigned to one of two groups. It's like flipping a coin to decide who gets which treatment

This study is about testing different treatments for non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable). The study involves giving patients an immunotherapy drug called nivolumab along with chemotherapy before they have surgery. Some patients will also receive a type of radiation therapy called stereotactic body radiation therapy (SBRT) before surgery, while others won't. The study is randomized and open-label, which means everyone knows which treatment they're getting. The goal is to see if adding nivolumab and SBRT to chemotherapy before surgery can improve outcomes for patients with resectable no- small cell lung cancer (NSCLC)

Site:

Einstein

NCT Number:

NCI-2022-06279

A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vsPembrolizumab Alone in Treatment-nave Subjects with Advanced or Metastatic PD-L1High (TPSgt50) Non-small-small Cell Lung Cancer Without Actionable Genomic Alterations(Tropion-Lung08)

This randomized study compares two treatments for advanced lung cancer that hasn't been treated before. One treatment combines two drugs, one called Dato-DXd and Pembrolizumab, a type of immunotherapy, while the other uses only Pembrolizumab. People in the study have a lot of a certain protein called PD-L1 in their cancer cells, and their cancer doesn't have any other specific genetic changes that can be targeted with existing drugs.

immunotherapy:

The immune system helps fight cancer by sending the body's defense (immune) system to kill the cancer cells. Immunotherapy drugs target cancer cells to prevent them from multiplying and growing.

Randomized:

Patients are randomly assigned to one of two groups. It's like flipping a coin to decide who gets which treatment

PD-L1:

PD-L1 is a protein that regulates the immune system's response to cancer cells, and helps cancer cells hide from the body's immune system.

Site:

Einstein

NCT Number:

NCI-2023-07361

A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) or Placebo in Combination with Chemotherapy (Carboplatin/Cisplatin-Etoposide) and Concurrent Radiotherapy in Patients with Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Phase 3:

A phase 3 clinical trial is a large-scale study designed to assess the effectiveness and safety of a new medical treatment or approach compared to a standard treatment

Small cell lung cancer:

A type of lung cancer with small cells that grow too much and can spread to other parts of the body

This Phase 3 study aims to determine if adding HLX10, a new type of cancer-fighting medicine, to standard chemotherapy and radiation therapy benefits patients with early stage small cell lung cancer (SCLC). It's being conducted internationally and involves giving HLX10 or a placebo alongside chemotherapy and radiation therapy. The goal is to assess HLX10's effectiveness and safety in treating this type of lung cancer.

Site:

Einstein

NCT Number:

NCI-2023-04004

A GLOBAL, PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF FURMONERTINIB COMPARED TO PLATINUM-BASED CHEMOTHERAPY AS FIRST-LINE TREATMENT FOR PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITH EPIDERMAL GROWTH FACTOR RECEPTOR EXON 20 INSERTION MUTATIONS

This is a large Phase 3 study happening in multiple locations worldwide. It aims to compare the effectiveness and safety of a drug called furmonertinib with platinum-based chemotherapy as the first treatment for patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have a specific genetic mutation called epidermal growth factor receptor exon 20 insertion. The study is open-label, meaning participants and researchers will know which treatment each person receives. The goal is to see if furmonertinib works better than chemotherapy for this type of lung cancer.

Phase 3:

A phase 3 clinical trial is a large-scale study designed to assess the effectiveness and safety of a new medical treatment or approach compared to a standard treatment

Epidermal growth factor receptor:

Epidermal Growth Factor Receptor (EGFR) is on the surface of cells and helps them grow and divide. In cancer, EGFR is like a switch that gets stuck in the "on" position, making cells grow and divide too much.

Mutation:

Mutation is an alteration in the genetic material of a cell or a virus that can be inherited by its descendants

Open-Label:

Patients know which treatments are being given to them

NSCLC:

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Site:

Einstein

NCT Number:

NCI-2022-09319

Pragmatica - Lung A Prospective Randomized Study of Ramucirumab (LY3009806 NSC 749128) Plus Pembrolizumab (MK-3475 NSC 776864) Versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer

This randomized study, called Pragmatica - Lung, is a research project where participants are randomly assigned to receive either a combination of two drugs, Ramucirumab and Pembrolizumab, or standard care. The participants have previously been treated with immunotherapy for stage IV or recurrent non-small cell lung cancer (NSCLC). The goal is to compare the effectiveness of the drug combination with the standard treatment for this type of cancer.

Randomized:

Patients are randomly assigned to one of two groups. It's like flipping a coin to decide who gets which treatment

Stage IV:

Stage IV cancer is when the cancer has spread to other organs

Immunotherapy:

The immune system helps fight cancer by sending the body's defense (immune) system to kill the cancer cells. Immunotherapy drugs target cancer cells to prevent them from multiplying and growing.

NSCLC:

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Site:

Einstein/Sinai/Columbia

NCT Number:

NCI-2021-14403

A Phase 2 Randomized Study of the BER Inhibitor TRC102 in Combination with Standard Pemetrexed-Platinum-Radiation in Stage III Non-Squamous Non-Small Cell Lung Cancer

This study aims to see if adding a new drug, TRC102, to the standard treatment for stage III non-squamous non-small cell lung cancer (NSCLC) can improve outcomes. TRC102 blocks an enzyme called BER, which cancer cells use to repair their DNA, potentially making cancer cells more sensitive to treatment. Patients diagnosed with stage III non-squamous NSCLC can participate. Participants will be randomly assigned to two groups: one receiving the standard treatment plus TRC102, the other receiving just the standard treatment. Both groups will be closely monitored for treatment response and side effects.

Estrogen Receptor positive HER-2 negative

It is a type of breast cancer where cancer cells have estrogen receptors and are stimulated by the hormone estrogen to grow. These cells also have very little of the protein HER-2. This type of cancer tends to respond very well to therapy, since it tends to grow slowly.

NSCLC: 

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Site:

Einstein

NCT Number:

NCI-2019-08627

A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC 783608) SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC

This study compares giving atezolizumab, an immunotherapy drug, along with stereotactic body radiotherapy (SBRT) to using SBRT alone in patients with early-stage non-small cell lung cancer (NSCLC). Atezolizumab is a drug that helps the body's immune system fight cancer cells. Patients will be randomly assigned to two groups: one receiving atezolizumab with SBRT, and the other receiving only SBRT. Both groups will be closely monitored for treatment response and side effects.

Stereotactic body radiotherapy:

A treatment method delivers strong and precise doses of radiation to cancerous tumors, aiming to get rid of cancer cells while sparing nearby healthy tissue from harm.

Immunotherapy:

The immune system helps fight cancer by sending the body's defense (immune) system to kill the cancer cells. Immunotherapy drugs target cancer cells to prevent them from multiplying and growing.

Site:

Einstein/Sinai

NCT Number:

NCI-2020-07076

A Phase 1 Study of SRF388 in Patients with Advanced Solid Tumors

This study aims to examine the safety and effectiveness of SRF388, a new drug, in treating patients with advanced solid tumors. People with advanced or metastatic solid tumors can participate.

Metastatic:

cancer that has spread from its original location or organ to other parts of the body. 

Site:

Sinai

NCT Number:

NCI-2021-09616

A Phase 1b/2 trial of Dupilumab given in conjunction with PD-(L)1 blockade in the treatment of relapsed/refractory metastatic NSCLC.

This trial investigates the effectiveness of Dupilumab, a medication that targets specific proteins invovled in inflammation, in combination with PD-L1 blockade, an immunotherapy medication, for treating relapsed/refractory metastatic non-small cell lung cancer (NSCLC). The study aims to determine how well the combination treatment works and its safety.

Triple Negative:

It is a type of breast cancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR), and HER-2 receptors.

Metastatic:

Cancer that has spread from its original location or organ to other parts of the body

Immunotherapy:

The immune system helps fight cancer by sending the body's defense (immune) system to kill the cancer cells. Immunotherapy drugs target cancer cells to prevent them from multiplying and growing.

Relapsed/Refractory:

Cancer that does not respond to treatment is called refractory and can be known as resistant cancer. The cancer may be resistant to therapy at the beginning of treatment or during treatment.

PD-L1:

PD-L1 is a protein that regulates the immune system's response to cancer cells, and helps cancer cells hide from the body's immune system.

Metastatic:

cancer that has spread from its original location or organ to other parts of the body.

NSCLC:

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Site:

Sinai

NCT Number:

NCI-2022-01956

A Phase I/IIa Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Participants With Advanced or Metastatic Solid Tumors

This phase I/IIa study aims to evaluate the safety, pharmacokinetics, and efficacy of a new drug, AZD7789, that can help the immune system better recognize and attack cancer cells, in participants with advanced or metastatic solid tumors. The study will assess the safety, effectiveness, and how well the treatment works
 

Phase I/IIa:

A study that assesses the safety, effectiveness, and how well the treatment works

Pharmacokinetics:

Pharmacokinetics studies how medicines move around in the body, including how they are absorbed, distributed, broken down, and removed.

Site:

Sinai

NCT Number:

NCI-2022-04561

A First-In-Human, Phase 1 a/b Dose Escalation and Expansion Study to Evaluate RBS2418 as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Unresectable, Recurrent or Metastatic Tumors

This Phase 1a/b study evaluates a drug RBS2418 as monotherapy and in combination with Pembrolizumab in subjects with advanced unresectable, recurrent, or metastatic tumors. Patients with these conditions can participate. The study aims to assess the safety, effectiveness, and recommended dosage of RBS2418atients.

Advanced:

Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

Metastatic:

cancer that has spread from its original location or organ to other parts of the body. 

Unresectable:

Unable to be removed through surgery

Site:

Sinai

NCT Number:

NCI-2023-03817

Phase 1b/2a safety and tolerability study of bemcentinib with pembrolizumab/carboplatin/pemetrexed in subjects with untreated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without/with a STK11 mutation

This Phase 1b/2a study assesses the safety and tolerability of a new drug called bemcentinib alongside pembrolizumab, carboplatin, and pemetrexed in treating non-squamous non-small cell lung cancer (NSCLC). Bemcentinib targets a protein involved in cancer growth, while pembrolizumab boosts the immune system, and carboplatin and pemetrexed are chemotherapy drugs. The goal is to assess the safety and effectiveness of this combination therapy in patients with advanced or spreading NSCLC,

NSCLC

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Site:

Sinai

NCT Number:

NCI-2023-04362

A Phase I, Open-label, Multicenter Study of ZL-1218 as a Single Agent and as Combination Therapy with Anti-PD-1 Antibody to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects with Advanced Solid Tumor Malignancies

In this Phase I study, researchers are looking at how a new medicine called ZL-1218 works for people with advanced cancer. They're testing it alone and with another treatment, an anti-PD-1 antibody, that helps the immune system fight cancer. The study is happening in multiple loactions, and the main goal is to find out if ZL-1218 is safe and how effective it is in treating advanced cancer.

Phase 1:

First step in testing a new medicine in people, and tests if treatment is safe, determines the right dose, and checks for any side effects.

Anti PD-1:

Blocks a specific protein (PD-1) that cancer cells use to hide from the immune system. By blocking this protein, the medicine makes it easier for the immune system to find and attack the cancer cells.

Site:

Sinai

NCT Number:

NCI-2023-10539

A Phase 1/2 study of combined treatment with dupilumab (anti-IL-4Ra) and cemiplimab (anti-PD-1) in patients with early-stage, resectable NSCLC

This study is exploring a new way to treat early-stage non small cell lung cancer that can be removed with surgery. They're testing two drugs together: Dupilumab, which fights inflammation and Cemiplimab, which helps the immune system fight cancer. The goal is to find out if this combination treatment is safe and effective.

NSCLC:

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Site:

Sinai

NCT Number:

NCI-2023-05619

A First-in-human, Multicenter, Open-label, Dose Escalation and Dose Expansion Phase 1 Study in Patients with Advanced Solid Tumors to Evaluate the Safety of Intravenously Administered ALG.APV-527

In this new study across multiple hospitals, researchers are investigating the safety of ALG.APV-527, a medication administered through a vein, in individuals with advanced solid tumors. The study involves gradually increasing the dose of the medication to find the highest amount that is safe for patients. By evaluating the safety of ALG.APV-527 in this Phase 1 study, researchers hope to pave the way for future investigations into its effectiveness against advanced solid tumors.

Phase 1:

First step in testing a new medicine in people, and tests if treatment is safe, determines the right dose, and checks for any side effects.

Site:

Sinai

NCT Number:

NCI-2019-01887

A Phase 1 Study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination With AGEN2034 (Balstilimab), an Anti-PD-1 Monoclonal Antibody, in Subjects With Advanced Cancer

This Phase 1 study evaluates AGEN1181, an immunotherapy medicine, for individuals with advanced cancer. They're examining how it works on its own and also when combined with another immunotherapy drug called AGEN2034. By testing these treatments, they aim to determine if they're safe and whether using them together could be more effective in treating advanced cancer

Immunotherapy:

The immune system helps fight cancer by sending the body's defense (immune) system to kill the cancer cells. Immunotherapy drugs target cancer cells to prevent them from multiplying and growing.

Site:

Sinai

NCT Number:

NCI-2022-10167

JZP815-101: Phase 1, FIH, open-label, nonrandomized, multicenter study of JZP815 in participants with advanced or metastatic solid tumors harboring alterations in the MAPK pathway

This Phase 1 study is looking at a drug called JZP815-101, and it is an open-label, nonrandomized, multicenter study of JZP815 in participants with advanced or metastatic solid tumors that have mutations in the MAPK pathway. The study aims to assess the safety, tolerability, and preliminary effectiveness of JZP815.

Phase 1:

First step in testing a new medicine in people, and tests if treatment is safe, determines the right dose, and checks for any side effects.

MAPK pathway:

The MAPK pathway is a communication system inside cells that regulates their growth, and when it malfunctions, it can contribute to cancer development

Site:

Sinai

NCT Number:

NCI-2022-06899

Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab With Pembrolizumab) in Combination With Concurrent Chemoradiotherapy Followed by MK-7684A Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III NSCLC

This open-label Phase 3 study is comparing two treatments for advanced lung cancer: MK-7684A, a combination of Vibostolimab and Pembrolizumab, and Durvalumab. These medications work by helping the immune system fight cancer cells. The study aims to determine which treatment is more effective and safer for individuals with advanced lung cancer that cannot be surgically removed.

Phase 3:

A phase 3 clinical trial is a large-scale study designed to assess the effectiveness and safety of a new medical treatment or approach compared to a standard treatment

Open-Label:

Patients know which treatments are being given to them

Site:

Sinai

NCT Number:

NCI-2023-09577

An open-label, multi-center phase I/Ib dose finding and expansion study of HRO761 as single agent and in combinations in patients with Microsatellite Instability-High or Mismatch Repair Deficient advanced solid tumors

In a Phase 1/1b study researchers are testing a new treatment called HRO761,for patients with advanced solid tumors that have a condition called Microsatellite Instability-High (MSI-H) or are Mismatch Repair Deficient (dMMR). The purpose of the study is to find the right dose of HRO761, both when used alone and in combination with other treatments, and to see how well it works in patients with these specific types of tumors.

(MSI-H) and (dMMR):

Microsatellite Instability-High (MSI-H) indicates a high level of DNA errors due to faulty repair mechanisms, while Mismatch Repair Deficient (dMMR) signifies ineffective correction of errors during DNA replication, both of which are associated with certain cancers.

Site:

Columbia

NCT Number:

NCI-2022-04033

A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CS5001, an Anti-ROR1 Antibody Drug Conjugate, in Patients with Advanced Solid Tumors and Lymphomas

This is a Phase I study where they'll test a new treatment called CS5001 on people with advanced solid tumors and lymphomas. They'll gradually increase the amount of CS5001 to find the safest dose and see how it affects the tumors. The goal is to check if CS5001 is safe, how it moves through the body, and if it can help fight these types of cancers.

Phase 1:

First step in testing a new medicine in people, and tests if treatment is safe, determines the right dose, and checks for any side effects.

Site:

Columbia

NCT Number:

NCI-2022-04663

A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BLU-222 as a Single Agent and in Combination Therapy for Patients with Advanced Solid Tumors

This Phase 1/2 study is looking at a drug called BLU-222 to see if it is safe and effective for treating advanced solid tumors. Researchers will test BLU-222 both on its own and in combination with other therapies. The main goals of the study are to understand how BLU-222 behaves in the body (pharmacokinetics), assess its safety, and determine if it can shrink tumors and improve patient outcomes

Phase 1/2:

Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.

Site:

Columbia

NCT Number:

NCI-2022-05170

A Multicenter Open-Label Study of RMC-6236 in Patients with Advanced Solid Tumors Harboring Specific Mutations in RAS

This study is investigating a drug called RMC-6236 in patients with advanced solid tumors that have specific mutations in a gene called RAS. The study is being conducted at multiple centers and is open-label, meaning that both the patients and researchers know which treatment is being administered. The main objective of the study is to evaluate the safety and effectiveness of RMC-6236 in treating these advanced solid tumors with RAS mutations.

RAS:

RAS mutations are alterations in certain genes controlling cell growth and division.

Site:

Columbia

NCT Number:

RAS:

RAS mutations are alterations in certain genes controlling cell growth and division

NCI-2023-01949

A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3789 in Participants withSelect Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation

This Phase 1 study is investigating a drug called PRT3789 in participants diagnosed with specific advanced or metastatic solid tumors that have a mutation in the SMARCA4 gene. The study is open-label and conducted at multiple centers, meaning that both participants and researchers are aware of the treatment being administered. The main objectives of the study are to assess the safety and effectiveness of PRT3789 in treating these types of tumors with SMARCA4 mutations.

Phase 1:

First step in testing a new medicine in people, and tests if treatment is safe, determines the right dose, and checks for any side effects.

Advanced:

Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

Metastatic:

cancer that has spread from its original location or organ to other parts of the body. 

Mutation:

Mutation is an alteration in the genetic material of a cell or a virus that can be inherited by its descendants

SMARCA4:

A gene that provides instructions for making a protein that regulates cell growth and function

Site:

Columbia

NCT Number:

NCI-2022-09147

A Phase 1 Study of ASP3082 in Participants with Previously Treated Locally Advanced or Metastatic Solid Tumor Malignancies with KRAS G12D Mutation

This Phase 1 study is investigating a drug called ASP3082 in participants who have locally advanced or metastatic solid tumors that have previously been treated and carry a specific genetic mutation called KRAS G12D. The study aims to assess the safety and effectiveness of ASP3082 in this patient population. The goal is to gather important data on how well ASP3082 works against tumors with the KRAS G12D mutation and to evaluate its safety profile in participants who have already undergone prior treatment for their cancer.

Phase 1:

First step in testing a new medicine in people, and tests if treatment is safe, determines the right dose, and checks for any side effects.

KRAS:

A KRAS mutation is a specific type of alteration in the KRAS gene, which is part of the RAS gene family. These mutations can lead to uncontrolled cell growth and are commonly found in various cancers, impacting treatment outcomes and guiding therapeutic strategies.

Metastatic:

cancer that has spread from its original location or organ to other parts of the body.

Locally Advanced:

Cancer which has grown larger into nearby tissues or organs, but hasn’t moved far from where it started

Site:

Columbia

NCT Number:

NCI-2022-09176

A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY OF ORAL MRT-2359 IN PATIENTS WITH MYC-DRIVEN AND OTHER SELECTED SOLID TUMORS INCLUDING LUNG CANCER AND DIFFUSE LARGE B-CELL LYMPHOMA

The "ATTACC" study is a Phase 1b/2 clinical trial investigating combinations of an ATR inhibitor called RP-3500 and PARP inhibitors in patients with specific cancers. The study aims to evaluate the safety and effectiveness of these combinations. By targeting both pathways, researchers hope to achieve enhanced anticancer activity against the selected cancers.

Site:

Columbia

NCT Number:

NCI-2023-03139

A Study of PARG Inhibitor IDE161 in Participants with Advanced Solid Tumors

This study is investigating the use of a new medicine called IDE161 in participants with advanced solid tumors. The main purpose of the study is to evaluate the safety and efficacy of IDE161 in this patient population. The researchers aim to assess how well IDE161 works in shrinking tumors and whether it has manageable side effects.

Triple Negative:

It is a type of breast cancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR), and HER-2 receptors.

Metastatic:

Cancer that has spread from its original location or organ to other parts of the body

Advanced:

Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

Site:

Columbia

NCT Number:

NCI-2020-06147

MORAb-202-G000-201: A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a folate receptor alpha (FR?)-targeting antibody-drug conjugate (ADC) in Subjects With Selected Tumor Types

This is a Phase 1/2 multicenter, open-label trial evaluating the safety, tolerability, and efficacy of a new drug called MORAb-202. The study aims to assess the safety profile of MORAb-202 and determine its effectiveness in treating specific tumor types that express FRα.

Triple Negative Breast Cancer:

It is a type of breast cancecancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR), and HER-2 receptors.

Metastatic:

Cancer that has spread from its original location or organ to other parts of the body

Phase 1/2:

Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.

Site:

Columbia

NCT Number:

NCI-2022-00633

A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 Monotherapy and in Combination with Pembrolizumab in Subjects with Selected Advanced Solid Tumors

This Phase 1a/1b study is designed to evaluate the safety and tolerability of a drug called STK-012 on its own and in combination with pembrolizumab, an immunotherapy medicine, for selected advanced solid tumors. The study aims to assess the safety profile of STK-012 when administered alone and in combination with pembrolizumab. Researchers will also evaluate the effectiveness of these treatments in shrinking tumors and improving patient outcomes.

Advanced:

Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

Immunotherapy:

The immune system helps fight cancer by sending the body's defense (immune) system to kill the cancer cells. Immunotherapy drugs target cancer cells to prevent them from multiplying and growing.

Site:

Columbia

NCT Number:

NCI-2022-06813

A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, andPreliminary Antitumor Activity of NDI-101150 Administered as Monotherapy or in Combination withPembrolizumab in Patients with Solid Tumors

This Phase 1/2 open-label study is looking at a new drug called NDI-101150 in people with solid tumors to see if it's safe and if it works against cancer. They'll give NDI-101150 alone or with another drug called pembrolizumab, which helps the immune system fight cancer. The goal is to check if NDI-101150 is safe, how it moves through the body, and if it can help shrink tumors, possibly working even better when combined with pembrolizumab.

Phase 1/2:

Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.

Site:

Columbia

NCT Number:

NCI-2021-04132

Phase 1 Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-6306 in Patients with Advanced Solid Tumors (MYTHIC Study)

The MYTHIC study is a Phase 1 clinical trial evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RP-6306 in patients with advanced solid tumors. RP-6306 is an investigational drug being studied to assess its safety profile, how it is processed in the body (pharmacokinetics), its effects on the body (pharmacodynamics), and its potential clinical benefits in treating advanced solid tumors

Phase 1:

First step in testing a new medicine in people, and tests if treatment is safe, determines the right dose, and checks for any side effects.

Pharmacokinetics:

Pharmacokinetics studies how medicines move around in the body, including how they are absorbed, distributed, broken down, and removed. 

Pharmacodynamics:

Study of how a drug affects the body, how is works, its effects, and how it interacts with its target

Advanced:

Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

Site:

Columbia

NCT Number:

NCI-2023-05813

A Phase 3, Open-Label, Randomized, Multi-Center Study ofDZD9008 versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation

This Phase 3 study is comparing a new treatment called DZD9008 with standard chemotherapy as the first treatment for patients with a specific type of lung cancer called non-small cell lung cancer (NSCLC) that has a particular genetic change called EGFR exon 20 insertion mutation. DZD9008 targets this specific mutation. The study aims to see if DZD9008 works better and is safer than standard chemotherapy for these patients, with the goal of finding a better treatment option for people with NSCLC who have this specific genetic change.

Phase 3:

A phase 3 clinical trial is a large-scale study designed to assess the effectiveness and safety of a new medical treatment or approach compared to a standard treatment

EGFR:

Epidermal Growth Factor Receptor (EGFR) is on the surface of cells and helps them grow and divide. In cancer, EGFR is like a switch that gets stuck in the "on" position, making cells grow and divide too much.

NSCLC:

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Site:

Columbia

NCT Number:

NCI-2020-04796

First-in-Human, Phase 1/1b, Open-label, Multicenter Study ofBifunctional EGFR/TGF? Fusion Protein BCA101 Monotherapyand in Combination Therapy in Patients with EGFR-DrivenAdvanced Solid Tumors

This is a Phase 1/1b first-in-human study designed to investigate the safety, efficacy, and tolerability of BCA101, a novel treatment that targets both EGFR (epidermal growth factor receptor) and TGFβ (transforming growth factor beta), in patients with advanced solid tumors driven by EGFR. BCA101 will be assessed both on its own and when used with other treatments, aiming to inhibit EGFR signaling and modify the tumor microenvironment by targeting TGFβ, ultimately aiming for improved anti-tumor effects.

EGFR:

Epidermal Growth Factor Receptor (EGFR) is on the surface of cells and helps them grow and divide. In cancer, EGFR is like a switch that gets stuck in the "on" position, making cells grow and divide too much.

Site:

Columbia

NCT Number:

NCI-2019-07236

A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients with Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy

This Phase 1/2 open-label, multi-center trial aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CLN-081 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who have previously undergone chemotherapy. The research aims to understand how CLN-081 works, its effects on tumors and the body, and if it can help shrink tumors and improve outcomes for patients who have not responded well to previous chemotherapy.

Phase 1/2:

Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.

Metastatic:

cancer that has spread from its original location or organ to other parts of the body.

Advanced:

Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

EGFR:

Epidermal Growth Factor Receptor (EGFR) is on the surface of cells and helps them grow and divide. In cancer, EGFR is like a switch that gets stuck in the "on" position, making cells grow and divide too much.

Site:

Columbia

NCT Number:

NCI-2023-00135

A Phase I/IIa, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Anti-tumor Activity of H002 in Patients with Active Epidermal Growth Factor Receptor Mutation Locally Advanced or Metastatic Non-small Cell Lung Cancer

This Phase I/IIa study involves testing a drug named H002 in patients diagnosed with locally advanced or metastatic non-small cell lung cancer (NSCLC) that carries a specific genetic mutation called epidermal growth factor receptor (EGFR) mutation. The study is divided into two parts: dose escalation and expansion. Researchers will gradually increase the dose of H002 to find the safest and most effective dose, and then expand the study to evaluate its effectiveness in a larger group of patients. The main objectives are to assess the safety, tolerability, how the body processes the drug (pharmacokinetics), and its initial effectiveness in treating NSCLC.

Phase I/IIa:

A study that assesses the safety, effectiveness, and how well the treatment works

EGRF:

Epidermal Growth Factor Receptor (EGFR) is on the surface of cells and helps them grow and divide. In cancer, EGFR is like a switch that gets stuck in the "on" position, making cells grow and divide too much.

metastatic:

cancer that has spread from its original location or organ to other parts of the body.

pharmacokinetics:

Pharmacokinetics studies how medicines move around in the body, including how they are absorbed, distributed, broken down, and removed.

Mutation:

Mutation is an alteration in the genetic material of a cell or a virus that can be inherited by its descendants

NSCLC:

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Site:

Columbia

NCT Number:

NCI-2022-03173

A Phase III, Double-blind, Randomised, Placebo-Controlled,International Study to assess the Efficacy and Safety of Adjuvant Osimertinib versus Placebo in Participants with EGFR mutation-positive Stage IA2-IA3 Non-small Cell Lung Cancer, following Complete Tumour Resection (ADAURA2)

The ADAURA2 study, a Phase III trial, seeks to assess the efficacy and safety of osimertinib compared to a placebo in patients with early-stage lung cancer harboring the EGFR mutation, following complete tumor resection. This international, double-blind, randomized study aims to determine if osimertinib after surgery can prevent cancer recurrence after surgery in this specific patient population.

EGFR:

Epidermal Growth Factor Receptor (EGFR) is on the surface of cells and helps them grow and divide. In cancer, EGFR is like a switch that gets stuck in the "on" position, making cells grow and divide too much.

Mutation:

Mutation is an alteration in the genetic material of a cell or a virus that can be inherited by its descendants

Site:

Columbia

NCT Number:

NCI-2020-01859

NAUTIKA1: A MULTICENTER, PHASE II, NEOADJUVANT AND ADJUVANT STUDY OF MULTIPLE THERAPIES IN BIOMARKER-SELECTED PATIENTS WITH RESECTABLE STAGES IB?III NON-SMALL CELL LUNG CANCER

The NAUTIKA1 trial, a Phase II study conducted across multiple medical centers, focuses on patients with resectable stages IB-III non-small cell lung cancer, who are selected based on specific biomarkers. The study examines various treatments administered before and after surgery.

Phase 2:

An advanced point of testing, where they're trying to confirm if a treatment works well.

NSCLC:

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Site:

Columbia

NCT Number:

NCI-2022-00860

Phase 1/2 Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT7480 in Patients With Nectin-4 Associated Advanced Malignancies

In this Phase 1/2 study, researchers are investigating BT7480, a potential treatment, in patients who have advanced malignancies associated with Nectin-4. They aim to understand how safe the treatment is, how it moves through the body, and its initial effectiveness in treating these types of cancers.

Phase 1/2:

Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.

Site:

Columbia

NCT Number:

NCI-2023-00610

A Phase 1, First-in-Human, Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb�808 in Combination with Pembrolizumab in Selected Advanced Solid Tumors

A Phase 1 study, which is the first of its kind in humans, is being conducted to find the appropriate dose and expand the investigation of XmAb®808 when used alongside Pembrolizumab, an immunotherapy medicine, in specific advanced solid tumors. The study aims to assess the safety, tolerance, how the body processes the drugs, and their effectiveness in treating these types of cancers.

Phase 1:

First step in testing a new medicine in people, and tests if treatment is safe, determines the right dose, and checks for any side effects.

Advanced:

Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

The immune system helps fight cancer by sending the body's defense (immune) system to kill the cancer cells. Immunotherapy drugs target cancer cells to prevent them from multiplying and growing.

Immunotherapy:

Site:

Columbia

NCT Number:

NCI-2019-04523

A Phase 1/2 study of IDE196 in patients with solid tumors harboring GNAQ/11 mutations or PRKC fusions

It's a Phase 1/2 study looking at a drug called IDE196 in patients with certain types of solid tumors. These tumors have mutations in GNAQ/11 or PRKC genes.

Phase 1/2:

Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.

Site:

Columbia

NCT Number:

PHASE 2, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF DS-7300A, A B7-H3 ANTIBODY-DRUG-CONJUGATE (ADC), IN SUBJECTS WITH PRETREATED EXTENSIVE-STAGE SMALL CELL LUNG CANCER (ES-SCLC).

In this Phase 2 trial, which is conducted at multiple locations, researchers are investigating DS-7300A, a new treatment. This study focuses on individuals who have previously received treatment for extensive-stage small cell lung cancer (ES-SCLC). The goal is to evaluate the effectiveness and safety of DS-7300A in this patient population.

Phase 2:

An advanced point of testing, where they're trying to confirm if a treatment works well.

ES-SCLC:

Cancer which has spread from the lungs to other areas of the body

Site:

Einstein

NCT Number:

NCI-2019-04202

A Multi-Cohort Exploratory Study of Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC.

This is a study exploring cemiplimab, an immunotherapy medicine, before surgery for treating resectable lung cancer, liver cancer, and head and neck cancer in multiple groups.

Immunotherapy:

The immune system helps fight cancer by sending the body's defense (immune) system to kill the cancer cells. Immunotherapy drugs target cancer cells to prevent them from multiplying and growing.

Resectable:

Some patients have a tumor that is “resectable,” which means that it is able to be removed with surgery.

Site:

Sinai

NCT Number:

A phase 2 randomized study of osimertinib versus osimertinib plus chemotherapy for patients with metastatic EGFR-mutant lung cancers that have detectable EGFR mutant cfDNA in plasma after initiation of osimertinib treatment

It's a Phase 2 trial comparing osimertinib alone to osimertinib with chemotherapy for people with advanced lung cancer that has a certain genetic change with an EGFR mutation. They're looking specifically at those whose blood shows an EGFR mutation.

Fase 2:

An advanced point of testing, where they're trying to confirm if a treatment works well.

Mutation:

Mutation is an alteration in the genetic material of a cell or a virus that can be inherited by its descendants

Epidermal Growth Factor Receptor (EGFR) is on the surface of cells and helps them grow and divide. In cancer, EGFR is like a switch that gets stuck in the "on" position, making cells grow and divide too much.

EGFR:

Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

Advanced:

Site:

Columbia

NCT Number:

A Phase I/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti tumor Activity of DB-1311 in Subjects with Advanced/Metastatic Solid Tumors

It's a Phase I/2a study being conducted at multiple centers to investigate DB-1311, a new medicine. The study aims to assess its safety, how the body processes it, and its initial impact on advanced or metastatic solid tumors.

Phase 1/2a:

A study that assesses the safety, effectiveness, and how well the treatment works

Metastatic:

cancer that has spread from its original location or organ to other parts of the body.

Advanced:

Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

Site:

Columbia

NCT Number:

A phase 1 study of JNJ-86974680, an A2a receptor antagonist, administered asmonotherapy and in combination with cetrelimab and radiotherapy for advanced nonsmallcell lung cancer

This is a phase 1 study trying out a drug called JNJ-86974680 alone and with cetrelimab, an immunotherapy medication, and radiotherapy for advanced non small cell lung cancer.

Phase 1:

First step in testing a new medicine in people, and tests if treatment is safe, determines the right dose, and checks for any side effects.

Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

Advanced:

Immunotherapy:

The immune system helps fight cancer by sending the body's defense (immune) system to kill the cancer cells. Immunotherapy drugs target cancer cells to prevent them from multiplying and growing.

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

NSCLC:

Site:

Columbia

NCT Number:

Phase 1b, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRASG12C-Mutated Solid Tumors

This is a Phase 1b study taking place at various locations. They're testing varying doses of a drug called RMC-6291 alongside RMC-6236 in individuals with advanced solid tumors that have a specific KRASG12C mutation.

Advanced:

Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

KRASG12C:

A KRAS mutation is a specific type of alteration in the KRAS gene, which is part of the RAS gene family. These mutations can lead to uncontrolled cell growth and are commonly found in various cancers, impacting treatment outcomes and guiding therapeutic strategies.

Site:

Columbia

NCT Number:

A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, andEfficacy of AMG 193 in Combination With IDE397 in Subjects With Advanced MTAP-null SolidTumors

This is a Phase 1/2 study looking at whether a new drug called AMG 193, combined with another drug called IDE397, is safe and works well in people with advanced solid tumors that don't have a mutation in MTAP, an enyme that plays a role in DNA synthesis and repair.

Phase 1/2:

Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.

Site:

Columbia

NCT Number:

NCI-2024-01143

A Randomized, Double-Blind PHase 2/3 Study of Fianlimab (Anti-Lag-3 Antibody), Cemiplimab (Anti-PD-1 Antibody), and Chemotherapy Versus Cemiplimab and Chemotherapy in Frist-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Irrespective of PD-L1 Expression Levels

It's a Phase 2/3 study on a new immunotherapy drug called Fianlimab, comparing a combiantion of Fianlimab, Cemiplimab (an Anti-PD-1 Antibody), and chemotherapy to only Cemiplimab and chemotherapy in treating advanced non-small cell lung cancer (NSCLC). This research is double-blind, meaning both the researchers and participants are unaware of who is receiving each treatment.

Immunotherapy:

The immune system helps fight cancer by sending the body's defense (immune) system to kill the cancer cells. Immunotherapy drugs target cancer cells to prevent them from multiplying and growing.

Anti-PD-1 Antibody:

Blocks a specific protein (PD-1) that cancer cells use to hide from the immune system. By blocking this protein, the medicine makes it easier for the immune system to find and attack the cancer cells.

Advanced:

Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

NSCLC:

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Site:

Sinai

NCT Number:

Phase 2 Trial of Neoadjuvant KRAS G12C directed therapy with Adagrasib (MRTX849) with or without Nivolumab in Resectable Non-Small Cell Lung Cancer (Neo-KAN)

In the Neo-KAN Phase 2 trial, researchers are exploring the use of Adagrasib (MRTX849), a targeted therapy aimed at the KRAS G12C mutation, before surgery in patients with non-small cell lung cancer. Some patients will receive Adagrasib alone, while others will receive it in combination with Nivolumab, a type of immunotherapy. The goal is to assess the effectiveness and safety of these treatments in preparing patients for surgical removal of their lung cancer.

Phase 2:

An advanced point of testing, where they're trying to confirm if a treatment works well.

KRASG12C:

A KRAS mutation is a specific type of alteration in the KRAS gene, which is part of the RAS gene family. These mutations can lead to uncontrolled cell growth and are commonly found in various cancers, impacting treatment outcomes and guiding therapeutic strategies.

Site:

Columbia

NCT Number:

NCI-2024-03452

A Phase 1, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose of D3S-002 Monotherapy in Adult Subjects with Advanced Solid Tumors with MAPK Pathway Mutations

This Phase 1 research study aims to evaluate the safety, tolerability, pharmacokinetics, and recommended Phase 2 dose of D3S-002 monotherapy in adults with advanced solid tumors harboring mutations in the MAPK pathway. Advanced Solid Tumors with MAPK Pathway Mutations are cancers where mutations in the MAPK pathway have been identified. The MAPK pathway is involved in cell growth and proliferation, and mutations can lead to uncontrolled cell growth, a hallmark of cancer. D3S-002 likely targets specific abnormalities in the MAPK pathway, aiming to inhibit cancer cell growth driven by these mutations.

Triple Negative Breast Cancer:

It is a type of breast cancecancer in which cells do not have estrogen receptors (ER), progesterone receptors (PR), and HER-2 receptors.

Metastatic:

Cancer that has spread from its original location or organ to other parts of the body

Advanced:

Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

Pharmacokinetics:

Pharmacokinetics studies how medicines move around in the body, including how they are absorbed, distributed, broken down, and removed.

Mutations:

Mutation is an alteration in the genetic material of a cell or a virus that can be inherited by its descendants

Site:

Sinai

NCT Number:

A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies

This Phase 1/1b research study evaluates the safety, tolerability, and preliminary efficacy of AB801 as monotherapy and in combination therapy for participants with advanced malignancies. It aims to establish the safety profile, optimal dosing, and potential benefits of AB801 in treating various types of advanced cancers, addressing significant clinical needs in oncology. The trial includes participants with various types of advanced cancers. This broad inclusion criterion allows for a diverse assessment of AB801's effects across different cancer types.

Advanced:

Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

Site:

Sinai

NCT Number:

NCI-2024-04758

A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SNS-101 (anti-VISTA) as Monotherapy and in Combination with Cemiplimab in Patients with Advanced Solid Tumors

This Phase 1/2 open-label study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101 (an anti-VISTA therapy) as monotherapy and in combination with cemiplimab (a PD-1 inhibitor) in patients with advanced solid tumors. SNS-101 targets VISTA, a checkpoint protein that can suppress immune responses against cancer cells. Inhibiting VISTA aims to enhance the body's immune system to fight cancer. Evaluating SNS-101 in combination with cemiplimab leverages the potential synergies between inhibiting VISTA and blocking PD-1, potentially leading to more effective treatment outcomes.

Open Label:

Patients know which treatments are being given to them

Pharmacokinetics:

Pharmacokinetics studies how medicines move around in the body, including how they are absorbed, distributed, broken down, and removed.

Pharmacodynamics:

Study of how a drug affects the body, how is works, its effects, and how it interacts with its target

Advanced:

Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

Site:

Sinai

NCT Number:

NCI-2017-01360

A PHASE II/III MULTICENTER STUDY EVALUATING THEEFFICACY AND SAFETY OF MULTIPLE TARGETED THERAPIES AS TREATMENTS FOR PATIENTS WITH ADVANCED OR METASTATIC NON?SMALL CELL LUNG CANCER (NSCLC) HARBORING ACTIONABLE SOMATIC MUTATIONS DETECTED IN BLOOD (B-FAST BLOOD-FIRST ASSAY SCREENING TRIAL)

This is a Phase II/III multicenter study focused on evaluating the effectiveness and safety of multiple targeted therapies for patients with advanced or metastatic non-small cell lung cancer (NSCLC). The study is specifically targeting patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have actionable somatic mutations detected in blood samples. These mutations are genetic alterations in the cancer cells that can be targeted by specific therapies designed to interfere with the growth and spread of cancer. The trial evaluates multiple targeted therapies. These therapies are tailored to specifically target the identified somatic mutations detected in the blood of the patients enrolled in the study. Targeted therapies aim to disrupt specific molecular pathways involved in cancer growth, potentially leading to more effective treatment outcomes with fewer side effects compared to traditional chemotherapy. The primary goal of this study, known as the B-FAST (Blood-First Assay Screening Trial), is to assess how well these targeted therapies work in treating advanced or metastatic NSCLC with actionable somatic mutations detected in blood samples. The study will also evaluate the safety profiles of these treatments in this patient population.

Metastatic:

cancer that has spread from its original location or organ to other parts of the body.

Advanced:

Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

Mutations:

Mutation is an alteration in the genetic material of a cell or a virus that can be inherited by its descendants

NSCLC:

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Site:

Einstein

NCT Number:

NCI-2019-02609

A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab with Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with Stage I/II, lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515)

This research study compares the new treatment (durvalumab with SBRT) with the current standard of care (placebo with SBRT) to evaluate its effectiveness and safety in a larger group of patients. Durvalumab is an immunotherapy drug that works by blocking a protein called PD-L1 on cancer cells, allowing the immune system to recognize and attack the cancer cells more effectively. Stereotactic Body Radiation Therapy (SBRT) is a type of radiation therapy that delivers high doses of radiation precisely to the tumor while minimizing damage to surrounding healthy tissue. It is commonly used in the treatment of early-stage non-small cell lung cancer. The study includes patients with stage I/II, lymph-node negative non-small cell lung cancer. These patients have tumors that are localized and have not spread to nearby lymph nodes. The primary objective of PACIFIC-4 (RTOG-3515) is to evaluate whether adding durvalumab to SBRT improves outcomes compared to SBRT alone in patients with early-stage non-small cell lung cancer. This includes assessing progression-free survival (the time until the cancer worsens), overall survival, and the safety profile of the treatment regimen.

Immunotherapy:

The immune system helps fight cancer by sending the body's defense (immune) system to kill the cancer cells. Immunotherapy drugs target cancer cells to prevent them from multiplying and growing.

Early stage:

Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.

NSCLC:

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Site:

Einstein

NCT Number:

NCI-2022-08263

Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally-Advanced Non-Small Cell Lung Cancer

This research study investigates whether combining SBRT for the primary lung tumor with concurrent mediastinal chemoradiation improves outcomes for patients with locally-advanced NSCLC compared to standard treatments. This refers to lung cancers that are more advanced than early-stage (stage I or II) but have not spread extensively to distant parts of the body (stage III). SBRT is a technique where very precise, high-dose radiation is delivered to the tumor, typically in a few (often 1-5) sessions. It's used for localized tumors and aims to deliver radiation with minimal damage to surrounding healthy tissue.

Site:

Einstein

NCT Number:

A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer

This Phase 3 research study compares the efficacy of adjuvant V940 (mRNA-4157) plus pembrolizumab against adjuvant placebo plus pembrolizumab in individuals with surgically removed Stage II, IIIA, and IIIB (N2) non-small cell lung cancer (NSCLC). It is randomized, double-blind, and includes both a placebo and an active comparator group. V940 (mRNA-4157) refers to an experimental mRNA-based therapeutic aimed at stimulating the immune response against cancer cells. Pembrolizumab is a type of immunotherapy that targets PD-1 (programmed cell death protein 1), enhancing the immune system's ability to fight cancer. The aim is to evaluate whether adding V940 to pembrolizumab improves outcomes for these patients compared to pembrolizumab alone.

Phase 3:

A phase 3 clinical trial is a large-scale study designed to assess the effectiveness and safety of a new medical treatment or approach compared to a standard treatment

Double Blind:

Neither the patients nor the doctors know who is getting what treatment. This helps make sure the results are completely not biased

Radomized:

Patients are randomly assigned to one of two groups. It's like flipping a coin to decide who gets which treatment

NSCLC:

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Placebo:

A placebo is a substance or treatment that has no active medical properties but is given to a patient as if it were a real medication or treatment. It is often used in medical research to compare the effects of a new drug or treatment with the effects of no treatment at all. The idea is to see if the new drug or treatment is genuinely effective by comparing how patients who receive the real treatment fare compared to those who receive the placebo

Site:

Einstein

NCT Number:

NCI-2023-08628

A Randomized Phase III Trial of Chemo-Immunotherapy vs Immunotherapy Alone for the Vulnerable Older Adult with Advanced Non-Small Cell Lung Cancer The ACHIEVE Study

The ACHIEVE Study is a randomized Phase 3 research study comparing chemo-immunotherapy (a combination of chemotherapy and immunotherapy) against immunotherapy alone for older adults who are vulnerable and have advanced non-small cell lung cancer (NSCLC). The study involves the combination of chemotherapy (which targets rapidly dividing cancer cells) and immunotherapy (which stimulates the immune system to fight cancer cells). The study aims to determine which treatment approach provides better outcomes in terms of efficacy and safety for this specific patient population.

Phase 3:

A phase 3 clinical trial is a large-scale study designed to assess the effectiveness and safety of a new medical treatment or approach compared to a standard treatment

Advanced:

Advanced breast cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

NSCLC:

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Site:

Einstein

NCT Number:

NCI-2024-00168

A Phase IIIb, Randomized, Multicenter, Open-label Study toassess the Efficacy of Durvalumab plus Tremelimumab versusPembrolizumab in Combination with Platinum-BasedChemotherapy for First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients with Non-Squamous Histology who have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS (TRITON)

The TRITON study is a Phase IIIb research study comparing two treatment approaches for metastatic non-small cell lung cancer patients with non-squamous histology and specific genetic mutations (STK11, KEAP1, or KRAS). It aims to determine whether durvalumab plus tremelimumab (immunotherapy drugs) is more effective than pembrolizumab plus platinum-based chemotherapy as first-line treatment. The trial is randomized, multicenter, and open-label, focusing on evaluating treatment efficacy and potentially improving outcomes for these patients. Durvalumab plus Tremelimumab are immunotherapy drugs that work by helping the immune system fight cancer cells. Durvalumab targets a protein called PD-L1, while tremelimumab enhances the immune response against cancer cells. Pembrolizumab is another immunotherapy drug that also targets PD-L1. It is combined with standard platinum-based chemotherapy, which is a common treatment approach for NSCLC. The goal of the TRITON trial is to determine which treatment regimen provides better outcomes in terms of effectiveness and potentially improving survival for patients with this specific type of lung cancer and genetic profile.

Site:

Columbia

NCT Number:

NCI-2024-03914

Phase 1 Trial of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RP-1664 in Participants with Advanced Solid Tumors

This Phase 1 clinical trial investigates RP-1664 in participants with advanced solid tumors. The study focuses on assessing the safety, pharmacokinetics (how the drug moves in the body), pharmacodynamics (how the drug affects the body), and initial clinical activity of RP-1664. The goal is to understand how well the drug works and its safety profile in treating advanced solid tumors.

Site:

Columbia

NCT Number:

NCI-2020-03931

A Phase 1 Study of SGN-B6A in Advanced Solid Tumors

This Phase 1 study investigates the safety and tolerability of SGN-B6A in patients with advanced solid tumors. It aims to determine the maximum tolerated dose of the drug while assessing its pharmacokinetics and preliminary effectiveness against various types of advanced solid cancers. The study sets the foundation for further research into SGN-B6A as a potential treatment option for these challenging conditions.

Site:

Columbia

NCT Number:

NCI-2023-06119

Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-186 (also known as MVC-101), An EGFR x CD3 COnditional Bispecific Redirected Activation (COBRA) Protein in Patients with Unresectable Locally Advanced or Metastatic Cancer CP-MVC-101-01

This is a Phase 1/2 research study is evaluating a novel treatment called TAK-186 (also known as MVC-101) in patients with unresectable locally advanced or metastatic cancer. TAK-186 is a type of treatment known as a conditional bispecific redirected activation (COBRA) protein. It is designed to target both the epidermal growth factor receptor (EGFR), which is often overexpressed in many cancers, and CD3, a protein found on T cells that helps activate an immune response against cancer cells. The study includes patients with unresectable locally advanced or metastatic cancer, meaning their cancer cannot be removed by surgery and has spread to nearby tissues or to other parts of the body. The primary objective of this trial, designated as CP-MVC-101-01, is to assess the safety profile of TAK-186/MVC-101 and gather preliminary data on its effectiveness in treating advanced cancers. If successful, the study may pave the way for further development and potential approval of TAK-186 as a new treatment option for these challenging types of cancer.

Site:

Columbia

NCT Number:

Metastatic:

Cancer that has spread from its original location or organ to other parts of the body

Metastatic:

Cancer that has spread from its original location or organ to other parts of the body

Metastatic:

Cancer that has spread from its original location or organ to other parts of the body

NCI-2020-04569

An Open-Label, Phase II Multicenter Study of Rituximab or Tocilizumab for Steroid-dependent or Steroid-refractory Immune-Related Adverse Events due to Immune Checkpoint Blockade.

This is a Phase II research study that is open-label and multicenter, focusing on evaluating two different treatments for immune-related adverse events (irAEs) caused by immune checkpoint blockade therapy. The study targets patients who have developed immune-related adverse events (irAEs) due to immune checkpoint blockade therapy. These adverse events can include a variety of side effects caused by the immune system attacking healthy tissues. The trial is comparing two treatments: Rituximab is a monoclonal antibody that targets a specific protein on the surface of immune cells, leading to their depletion. Rituximab is commonly used to treat certain autoimmune conditions and immune-related adverse events.
Tocilizumab is another monoclonal antibody that targets the interleukin-6 receptor, which is involved in immune responses. Tocilizumab is used to treat inflammatory conditions and has shown efficacy in managing some immune-related adverse events. The primary goal of the study is to evaluate whether rituximab or tocilizumab can effectively manage steroid-dependent or steroid-refractory immune-related adverse events caused by immune checkpoint blockade therapy. The study will assess both the effectiveness of these treatments in controlling the adverse events and their safety profiles in this specific patient population.

Site:

Columbia

NCT Number:

Metastatic:

Cancer that has spread from its original location or organ to other parts of the body

Metastatic:

Cancer that has spread from its original location or organ to other parts of the body

Metastatic:

Cancer that has spread from its original location or organ to other parts of the body

A Phase 3, Randomized, Double-blind,Placebo-controlled, Multicenter Study of Tarlatamab Therapy in Subjects WithLimited-Stage Small-Cell Lung Cancer (LS-SCLC) who Have not Progressed Following Concurrent ChemoradiationTherapy (DeLLphi-306) 

This is a Phase 3 study called DeLLphi-306, which is testing the drug Tarlatamab in people with Small-Cell Lung Cancer (LS-SCLC) who have not seen their cancer worsen after receiving chemoradiation therapy. The study is randomized, double-blind, placebo-controlled, and multicenter, meaning that participants are randomly assigned to different treatment groups, neither they nor the researchers know which treatment they're receiving, and the study is happening at multiple locations.

Phase 3:

A phase 3 clinical trial is a large-scale study designed to assess the effectiveness and safety of a new medical treatment or approach compared to a standard treatment

Chemoradiation:

Neither the patients nor the doctors know who is getting what treatment. This helps make sure the results are completely not biased

Radomized:

Patients are randomly assigned to one of two groups. It's like flipping a coin to decide who gets which treatment

SCLC:

A type of lung cancer with small cells that grow too much and can spread to other parts of the body

Placebo:

A placebo is a substance or treatment that has no active medical properties but is given to a patient as if it were a real medication or treatment. It is often used in medical research to compare the effects of a new drug or treatment with the effects of no treatment at all. The idea is to see if the new drug or treatment is genuinely effective by comparing how patients who receive the real treatment fare compared to those who receive the placebo

Site:

Einstein

NCT Number:

A multicentre, Phase II, single-arm, interventional study of neoadjuvant durvalumab and platinum-based chemotherapy(CT), followed by either surgery and adjuvant durvalumab or chemoradiotherapy (CRT) and consolidation durvalumab, in participants with resectable or borderline resectable stage IIB-IIIB Non-small Cell Lung Cancer (NSCLC)          

This is a Phase II study taking place at multiple hospitals to test a treatment for people with stage IIB-IIIB Non-Small Cell Lung Cancer (NSCLC) that can either be removed by surgery or is close to being able to be removed. First, patients will receive a combination of durvalumab, a drug that helps the immune system fight cancer, and platinum-based chemotherapy, which uses special drugs to kill cancer cells. After this, patients will either have surgery and then more durvalumab (called adjuvant durvalumab) or receive chemoradiotherapy (CRT), which combines chemotherapy and radiation, followed by more durvalumab (called consolidation durvalumab). The goal is to see how well this combination works in treating this type of lung cancer.

Phase 2:

An advanced point of testing, where they're trying to confirm if a treatment works well.

NSCLC:

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Site:

Einstein

NCT Number:

A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects with Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305)

This is a Phase 3 study called DeLLphi-305, testing a combination of two drugs, Tarlatamab and Durvalumab, compared to Durvalumab alone, in people with  Small-Cell Lung Cancer (SCLC). The patients in this study have already been treated with chemotherapy drugs like Platinum and Etoposide, along with Durvalumab. Tarlatamab is a new drug that helps the immune system recognize and attack cancer cells by targeting a specific protein on the cancer cells. Durvalumab is an immune therapy drug that helps the immune system fight cancer by blocking a protein on the cancer cells that stops immune cells from attacking. Platinum-based chemotherapy uses drugs with platinum to kill cancer cells by damaging their DNA, and Etoposide is another chemotherapy drug that stops cancer cells from dividing and growing. The study aims to see if combining Tarlatamab with Durvalumab is more effective than Durvalumab alone for treating this type of lung cancer.

Phase 3:

A phase 3 clinical trial is a large-scale study designed to assess the effectiveness and safety of a new medical treatment or approach compared to a standard treatment

SCLC:

A type of lung cancer with small cells that grow too much and can spread to other parts of the body

Site:

Einstein

NCT Number:

A Phase 2 Basket Study of Tucatinib in Combination with Trastuzumab in Subjects with Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations  

This is a Phase 2 basket study testing the combination of Tucatinib and Trastuzumab in patients with locally advanced unresectable or metastatic solid tumors that are driven by HER2 alterations. The patients in this study have previously been treated for their cancer. Tucatinib is a targeted therapy drug that works by blocking the HER2 protein, preventing cancer cells from receiving signals that help them grow. Trastuzumab (also known as Herceptin) is another drug that targets the HER2 protein on cancer cells and helps the immune system attack and destroy those cells. This study aims to test how effective the combination of these two drugs is in treating cancers that have changes (alterations) in the HER2 gene, which can cause certain cancers to grow faster.

Phase 2:

An advanced point of testing, where they're trying to confirm if a treatment works well.

Unresectable:

Unable to be removed through surgery

Site:

Sinai

NCT Number:

A Phase 1/2 Study of BA3071 in Patients with Solid Tumors

This is a multi-center, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of a drug called BA3071. Phase 2 of the study is currently recruiting patients with the following conditions: NSCLC with mutations in KRAS, STK11 and PD-L1 <1%.

Phase 2:

An advanced point of testing, where they're trying to confirm if a treatment works well.

Open Label:

Patients know which treatments are being given to them

Pharmacokinetics:

Pharmacokinetics studies how medicines move around in the body, including how they are absorbed, distributed, broken down, and removed.

NSCLC:

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

Site:

Sinai

NCT Number:

A Phase 1b/2 trial of Lamivudine in the Treatment of Relapsed/Refractory Solid Tumors Progression on Anti-PD-(L)1 blockade   

 In cancer treatment, Lamivudine is being explored for its potential to help fight cancer by improving the immune system's ability to attack tumors. While it is not typically used for cancer, some studies suggest that Lamivudine may have effects that could make immune therapies, like Anti-PD-(L)1 blockade, more effective. Anti-PD-(L)1 blockade therapies work by blocking a protein that prevents immune cells from attacking cancer cells, and Lamivudine might help enhance this process, especially in cancers that are not responding to other treatments. This is a phase 1b/2 trial. 

Anti PD(L)1:

Blocks a specific protein (PD-1) that cancer cells use to hide from the immune system. By blocking this protein, the medicine makes it easier for the immune system to find and attack the cancer cells.

Site:

Sinai

NCT Number:

A Platform Study of RAS(ON) Inhibitor Combinations in Patients with RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)   

This is a platform study testing different combinations of RAS(ON) inhibitors in patients with RAS-mutated Non-Small Cell Lung Cancer (NSCLC). RAS mutations are changes in a gene that can cause cancer cells to grow uncontrollably. The study is designed to find the most effective combination of treatments that target these mutations in order to help stop the cancer from growing. 

NSCLC:

A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

RAS Mutations:

RAS mutations are alterations in certain genes controlling cell growth and division.

Site:

Columbia

NCT Number:

Phase 1, open label single-arm two-part study to investigate safety, pharmacokinetics, andpreliminary efficacy of pan-RAF/MEK glue NST-628 oral tablets in subjects with solid tumorsharboring genetic alterations in the MAPK pathway and with other solid tumors     

This is a Phase 1, open-label, single-arm study with two parts to investigate the safety, how the body processes the drug, and the early effectiveness of a new drug, NST-628 oral tablets in patients with solid tumors that have genetic changes in the MAPK pathway, as well as other types of solid tumors. The goal is to determine how safe the drug is and how well it might work in treating these cancers. In this study, all participants will receive the same treatment, and researchers will first focus on its safety before assessing its effectiveness.

Phase 1:

First step in testing a new medicine in people, and tests if treatment is safe, determines the right dose, and checks for any side effects.

Open Label:

Patients know which treatments are being given to them

Single Arm Study:

A study where sample of individuals with the targeted medical condition is given the experimental therapy and then followed over time to observe their response.

MAPK:

The MAPK pathway is a communication system inside cells that regulates their growth, and when it malfunctions, it can contribute to cancer development

Site:

Columbia

NCT Number:

A PHASE 1B/2, MULTICENTER, OPEN-LABEL STUDY OF IFINATAMAB DERUXTECAN (I-DXd), A B7-H3 ANTIBODY-DRUG CONJUGATE (ADC), IN COMBINATION WITH ATEZOLIZUMAB WITH OR WITHOUT CARBOPLATIN AS FIRST-LINE INDUCTION OR MAINTENANCE, IN SUBJECTS WITH EXTENSIVE-STAGE SMALL CELL LUNG CANCER (ES-SCLC) 

This PHASE 1B/2, MULTICENTER, OPEN-LABEL study is testing a combination of three treatments for Extensive-Stage Small Cell Lung Cancer (ES-SCLC). Ifinatamab Deruxtecan (I-DXd) is an antibody-drug conjugate (ADC), which is a type of drug that combines an antibody (a protein that can specifically target cancer cells) with a chemotherapy drug. The antibody in I-DXd targets a protein called B7-H3 on cancer cells, delivering the chemotherapy directly to the cancer cells to kill them while minimizing damage to healthy cells. Atezolizumab is an immune checkpoint inhibitor that blocks a protein on cancer cells, helping the immune system recognize and attack the cancer. Carboplatin is a chemotherapy drug that works by damaging the DNA of cancer cells, stopping them from growing and dividing. The study aims to see if combining these drugs can be a more effective treatment for this advanced form of lung cancer.

Open Label:

Patients know which treatments are being given to them

ES-SCLC:

Cancer which has spread from the lungs to other areas of the body

Site:

Columbia

NCT Number:

LuMIERE: A Phase 1/2, Multicenter, Open-label, Non-randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of [177Lu]Lu-FAP-2286 in Patients with an Advanced Solid Tumor   

The LuMIERE study is a Phase 1/2 trial happening at multiple centers to test the safety, how the body processes, and how well the drug [177Lu]Lu-FAP-2286 works in patients with advanced solid tumors (cancers that have spread or are difficult to treat). The study is looking at how well the drug is tolerated by patients, how it moves through the body, how much radiation it delivers to the tumor, and if it can help treat these cancers. This is an open-label, non-randomized study, meaning all patients will receive the same treatment, and there is no random selection of treatments.

Phase 1/2:

Early phase (phases I and II) studies help researchers determine: Whether a new treatment is safe, what its side effects are and the best dose of the new treatment.

Open label:

Patients know which treatments are being given to them

Site:

Columbia

NCT Number:

An Open-Label Phase 1 Dose-Escalation and Expansion Study Investigating the Safety,Pharmacokinetics, Pharmacodynamics, and Activity of PRTH-101 Alone or in Combination with Pembrolizumab in Adults with Locally Advanced or Metastatic Solid Tumors 

This is an open-label Phase 1 study that tests the safety, how the body processes the drug, its effects, and how well it works. The study is investigating PRTH-101, both alone and in combination with Pembrolizumab, in adults with locally advanced or metastatic solid tumors (cancers that have spread or are hard to treat). The study will first test different doses of PRTH-101 to find the right amount, and then expand to include more patients to better understand how the drug works. PRTH-101 is being studied for its potential to help the immune system recognize and attack cancer by targeting specific proteins on tumor cells. Pembrolizumab is an immune checkpoint inhibitor that boosts the immune system by blocking a protein on cancer cells that helps them hide from immune detection, allowing the immune system to more effectively target and destroy the cancer cells.

Open Label:

Patients know which treatments are being given to them

Phase 1:

First step in testing a new medicine in people, and tests if treatment is safe, determines the right dose, and checks for any side effects.

Site:

Einstein

NCT Number:

A Phase I, Multicenter, Open-label, First-in Human, Dose Escalation and Expansion Study of AZD9592 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Tumors        

This is a Phase I study happening at multiple centers to test AZD9592 in people with advanced solid tumors (cancers that are hard to treat or have spread). This is a first-in-human study, meaning it’s the first time the drug is being tested in people. The study will test AZD9592 on its own and in combination with other cancer treatments. It will look at how safe the drug is, how it works in the body, and how well it can treat these cancers. The study will start by testing low doses of the drug and then increase the dose to find the best amount to use.

Phase 1:

First step in testing a new medicine in people, and tests if treatment is safe, determines the right dose, and checks for any side effects.

Site:

Sinai

NCT Number:

A Phase 1 Open-Label, Dose-Escalation and Cohort Expansion Study of LUNA18 Monotherapy and Combination Therapy in Patients with Locally Advanced or Metastatic Solid Tumors 

This is a Phase 1 study testing a drug called LUNA18 in patients with locally advanced or metastatic solid tumors (cancers that are hard to treat or have spread to other parts of the body). The study will look at how LUNA18 works on its own (called monotherapy) and also when combined with other treatments. The researchers will start with small doses and gradually increase them to find the best dose that works. The study is focused on checking how safe the drug is, how the body processes it, and how well it can treat these types of cancer. 

Phase 1:

​First step in testing a new medicine in people, and tests if treatment is safe, determines the right dose, and checks for any side effects.

Site:

Sinai

NCT Number:

A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants with Advanced or Metastatic 
Urothelial Carcinoma or Other Solid Tumors     

This is a Phase 1a/1b study testing a drug called LY4052031, which is an antibody-drug conjugate designed to target a protein called Nectin-4 on cancer cells. The study is for people with advanced or metastatic urothelial carcinoma (a type of bladder cancer) or other solid tumors (cancers that form in organs or tissues). The study will test how safe the drug is, how the body processes it, and how well it works to treat these cancers. It is designed to find the best dose of the drug and learn how it can help fight cancer.

Antibody:

Antibodies are part of our body's defense system. They are proteins found in the blood that can specifically recognize and remove foreign substances like bacteria or cancer in the body.

Site:

Sinai

NCT Number:

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