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Brief Title: REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer
Official Title: A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer
Study ID: NCT04077099
Brief Summary: The primary objective of the dose escalation (phase 1) part of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of REGN5093 for determination of the maximum tolerated dose (MTD) and/or definition of the recommended phase 2 dose (RP2D) of REGN5093 in patients with MET-altered Non-small cell lung cancer (NSCLC). The primary objective of the dose expansion (phase 2) part of the study is to assess preliminary anti-tumor activity of REGN5093 as measured by the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Regeneron Research Facility, Birmingham, Alabama, United States
Regeneron Research Facility, Orange, California, United States
Regeneron Research Facility, Washington, District of Columbia, United States
Regeneron Research Facility, Tampa, Florida, United States
Regeneron Research Facility, Lexington, Kentucky, United States
Regeneron Research Facility, Boston, Massachusetts, United States
Regeneron Research Facility, Detroit, Michigan, United States
Regeneron Research Facility, Saint Louis, Missouri, United States
Regeneron Research Facility, New York, New York, United States
Regeneron Research Facility, New York, New York, United States
Regeneron Research Facility, New York, New York, United States
Regeneron Research Facility, Durham, North Carolina, United States
Regeneron Research Facility, Oklahoma City, Oklahoma, United States
Regeneron Research Facility, Philadelphia, Pennsylvania, United States
Regeneron Research Facility, Pittsburgh, Pennsylvania, United States
Regeneron Research Facility, Dallas, Texas, United States
Regeneron Research Facility, Houston, Texas, United States
Regeneron Research Facility, Bordeaux Cedex 9, , France
Regeneron Study Site, Caen cedex, , France
Regeneron Research Facility, Dijon Cedex, , France
Regeneron Research Facility, Grenoble, , France
Regeneron Research Facility, Montpellier, , France
Regeneron Research Facility, Rennes Cedex 9, , France
Regeneron Research Facility, Gyeonggi do, Gyeonggi, Korea, Republic of
Regeneron Research Facility, Suwon, Gyeonggi, Korea, Republic of
Regeneron Research Facility, Seoul, , Korea, Republic of
Regeneron Research Facility, Seoul, , Korea, Republic of
Regeneron Research Facility, Seoul, , Korea, Republic of
Regeneron Research Facility, Seoul, , Korea, Republic of
Regeneron Research Facility, Seoul, , Korea, Republic of
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR