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NCT04077099PHASE1, PHASE2Recruiting

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

Regeneron Pharmaceuticals

Start Date

1/7/2020

Completion Date

4/22/2032

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 Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: 1. Histologically confirmed advanced NSCLC that is unresectable or metastatic as described in the protocol 2. Willing to provide tumor tissue as described in the protocol 3. Documented presence of MET alteration as described in the protocol. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 5. Adequate organ and bone marrow function as described in the protocol Key Exclusion Criteria: 1. Has received treatment with an approved systemic therapy or has participated in any study of an investigational agent or investigational device within 2 weeks as described in the protocol 2. Has not yet recovered from any acute toxicities resulting from prior therapy with certain exceptions as described in the protocol 3. Has received radiation therapy or major surgery within 14 days as described in the protocol 4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease or spinal cord compression as defined in the protocol 5. Uncontrolled infection as described in the protocol Note: Other protocol defined Inclusion/Exclusion criteria apply

Interventions

DRUG

REGN5093

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Conditions

NSCLC

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

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

Orange, California 92868

United States

Georgetown University Medical Center

Washington D.C., District of Columbia 20007

United States

Moffitt Cancer Center - McKinley Drive

Tampa, Florida 33612

United States

University of Kentucky, Markey Cancer Center Clinical Research Organization

Lexington, Kentucky 40536

United States

DNU_Massachusetts General Hospital_DNU

Boston, Massachusetts 02114

United States

Dana Farber Harvard Cancer Center Consortium

Boston, Massachusetts 02215

United States

Henry Ford Health System

Detroit, Michigan 48202

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

NYU Cancer Institute

New York, New York 10016

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Duke Cancer Center

Durham, North Carolina 27710

United States

Stephenson Cancer Center

Oklahoma City, Oklahoma 73104

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania 19111

United States

University of Pittsburgh UPMC - Clinical Research Services

Pittsburgh, Pennsylvania 15232

United States

Harold C. Simmons Comprehensive Cancer Center

Dallas, Texas 75235

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Centre Georges Francois Leclerc

Dijon, Bourgogne-Franche-Comté 21034

France

Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

Rennes, Bretange 35033

France

Institut Bergonie

Bordeaux, New Aquitaine 33076

France

Centre Francois Baclesse (CFB)

Caen, Normandy 14076

France

Centre Hospitalier Universitaire de Grenoble

Grenoble, 38043

France

Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve

Montpellier, 34295

France

National Cancer Center

Gyeonggi-do, Gyeonggi-do 10408

South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620

South Korea

The Catholic University Of Korea St. Vincent's Hospital

Suwon, Gyeonggi-do 16247

South Korea

Ajou University Hospital

Suwon, Gyeonggi-do 16499

South Korea

Haeundae Paik Hospital

Pusan, Gyeongsangnam-do 48108

South Korea

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do 58128

South Korea

Gachon University Gil Medical Center

Incheon, Namdong-gu 21565

South Korea

Chungbuk National University Hospital

Cheongju-si, North Chungcheong 28644

South Korea

Pusan National University Hospital

Busan, 49241

South Korea

Severance Hospital Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Seol St. Mary's Hospital

Seoul, 06591

South Korea

Boramae Medical Center

Seoul, 07061

South Korea

Korea University Guro Hospital

Seoul, 08308

South Korea

Seoul National University Hospital

Seoul, 3080

South Korea