A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer
Recruiting · NCT04077099 · Interventional (participants receive a specific treatment) · Lead sponsor: Regeneron Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
REGN5093
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Histologically confirmed advanced NSCLC that is unresectable or metastatic as described in the protocol
- Willing to provide tumor tissue as described in the protocol
- Documented presence of MET alteration as described in the protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function as described in the protocol
- Key
Exclusion criteria
- 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
- Has not yet recovered from any acute toxicities resulting from prior therapy with certain exceptions as described in the protocol
- Has received radiation therapy or major surgery within 14 days as described in the protocol
- Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease or spinal cord compression as defined in the protocol
- Uncontrolled infection as described in the protocol
- Note: Other protocol defined Inclusion/Exclusion criteria apply
Where it is running
40 locations listed across 13 US states.
- 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
- Pusan National University Hospital - Busan, South Korea
- Centre Hospitalier Universitaire de Grenoble - Grenoble, France
- Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve - Montpellier, France
- Severance Hospital Yonsei University Health System - Seoul, 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
- Centre Georges Francois Leclerc - Dijon, Bourgogne-Franche-Comté, France
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou - Rennes, Bretange, 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
- Institut Bergonie - Bordeaux, New Aquitaine, France
- Centre Francois Baclesse (CFB) - Caen, Normandy, France
- Chungbuk National University Hospital - Cheongju-si, North Chungcheong, South Korea