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

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

Targeted disease: 
Lung Cancer

Purpose of study:
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)

Is the study of a controlled or observational design? 
Controlled

Where is the study being conducted?
Multi-Center Trial

Lead Institution:
Regeneron Pharmacuticals

City and State: 
Regeneron Research Facility Orange, California, United States, 92868; Regeneron Research Facility    Washington, District of Columbia, United States, 20007; Regeneron Research Facility Durham, North Carolina, United States, 27710; Regeneron Research Facility Oklahoma City, Oklahoma, United States, 73104;  Pennsylvania Regeneron Research Facility Pittsburgh, Pennsylvania, United States, 15232; Regeneron Research Facility Seoul, Korea, Republic of, 03080

When the study is being conducted: 
Start Date: 1/7/2020
End date: 2/15/2024

What website should a person use to register for the study?
Massivebio.com

Who should a person contact to register for the study?
Name: Massive Bio
Phone: 844-627-7246
Email: [email protected]

Who is sponsoring this study?
Regeneron Pharmaceuticals

What is the identifier for this study on ClinicalTrials.gov?
NCT04077099

Page last updated: August 17, 2020

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