Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Adult Patients With Mesenchymal Epithelial Transition Factor (MET) Overexpressing Advanced Cancer
Stopped early · Phase 1
Conditions studied: Advanced NSCLC
In brief
This study is researching an experimental drug called REGN5093-M114 by itself and in combination with cemiplimab. The study is focused on advanced non-small cell lung cancer (NSCLC) that produces too much of a protein called mesenchymal epithelial transition factor (MET) on the cancer cell surface. The aim of the study is to see how safe, tolerable, and effective the study drug is. This study will include 3 study groups, or cohorts, and each group is split into 2 parts: Part 1: The main purpose of part 1 is to determine a safe dose of REGN5093-M114 (Cohorts A and B), and in combination with cemiplimab (Cohort C). Part 2: The main purpose of part 2 is to use the REGN5093-M114 dose found for each cohort in part 1 to see how well the study drug works to shrink tumors. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drug * Does the study drug work to reduce or delay the progression of your cancer * How much study drug is in the blood at different times * Does the body make antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Key facts
- Study ID
- NCT04982224
- Run by
- Regeneron Pharmaceuticals
- People needed
- 30
- Starts
- 2021-11-09
- Expected to finish
- 2025-10-15
- Last updated by the study team
- 2025-11-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of California Irvine School of Medicine - Suite 400, Room 407 — Orange, California, United States
- University of Colorado Hospital Anshutz Outpatient Pavillion — Denver, Colorado, United States
- Johns Hopkins Hospital - Clinical Study Location - Skip Viragh Outpatient Cancer Building — Baltimore, Maryland, United States
- Sidney Kimmel Comprehensive Cancer Center - 4F Second Medical Building — Baltimore, Maryland, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Henry Ford Hospital, Henry Ford Cancer Institute — Detroit, Michigan, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- University of Pittsburgh Medical Center - Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
- MUSC Hollings Cancer Center — Charleston, South Carolina, United States
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- Next Virginia — Fairfax, Virginia, United States
Full record on ClinicalTrials.gov
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