RecruitingPhase 1Phase 2NCT04077099

A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer

A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer

Sponsor

Regeneron Pharmaceuticals

Enrollment

231 participants

Start Date

Jan 7, 2020

Study Type

INTERVENTIONAL

Conditions

NSCLC

Summary

This study will evaluate REGN5093 for the treatment of Non-Small Cell Lung Cancer (NSCLC) with MET alteration. The main purpose of this study is to determine the safety, tolerability, and effectiveness of REGN5093. The study has two phases. The main goal of Phase 1 is to determine a safe dose(s) of REGN5093. The main goal of phase 2 of the study is to use the REGN5093 drug dose(s) found in Phase 1 to see how well REGN5093 works to shrink tumors. The study is looking at several other research questions, including: * Side effects that may be experienced by people taking REGN5093 * How REGN5093 works in the body * How much REGN5093 is present in the blood * To see if REGN5093 works to reduce or delay the progression of cancer * How long it takes REGN5093 to work in the body

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called REGN5093 in people with advanced non-small cell lung cancer (NSCLC) whose tumors have a specific genetic change called a MET alteration. MET is a protein that, when altered, drives cancer growth — and REGN5093 is designed to block it. **You may be eligible if...** - You have been diagnosed with advanced or metastatic non-small cell lung cancer that cannot be surgically removed - Your tumor has a documented MET alteration (confirmed by testing) - You are in good health overall (ECOG performance status 0 or 1) - Your major organs (bone marrow, kidneys, liver) are functioning adequately - You are willing to provide tumor tissue samples **You may NOT be eligible if...** - You received systemic cancer treatment or participated in another investigational study within the past 2 weeks - You have not fully recovered from side effects of prior treatment - You received recent radiation therapy - You have other conditions that make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGREGN5093

Intravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase.

Locations(40)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California Irvine Medical Center - Bldg 56, RT81, Rm 241

Orange, California, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Moffitt Cancer Center - McKinley Drive

Tampa, Florida, United States

University of Kentucky, Markey Cancer Center Clinical Research Organization

Lexington, Kentucky, United States

DNU_Massachusetts General Hospital_DNU

Boston, Massachusetts, United States

Dana Farber Harvard Cancer Center Consortium

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

NYU Cancer Institute

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke Cancer Center

Durham, North Carolina, United States

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh UPMC - Clinical Research Services

Pittsburgh, Pennsylvania, United States

Harold C. Simmons Comprehensive Cancer Center

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Centre Georges Francois Leclerc

Dijon, Bourgogne-Franche-Comté, France

Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

Rennes, Bretange, France

Institut Bergonie

Bordeaux, New Aquitaine, France

Centre Francois Baclesse (CFB)

Caen, Normandy, France

Centre Hospitalier Universitaire de Grenoble

Grenoble, France

Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve

Montpellier, France

National Cancer Center

Gyeonggi-do, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

The Catholic University Of Korea St. Vincent's Hospital

Suwon, Gyeonggi-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Haeundae Paik Hospital

Pusan, Gyeongsangnam-do, South Korea

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

Gachon University Gil Medical Center

Incheon, Namdong-gu, South Korea

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

Pusan National University Hospital

Busan, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seol St. Mary's Hospital

Seoul, South Korea

Boramae Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

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NCT04077099

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