Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Adult Patients With Mesenchymal Epithelial Transition Factor (MET) Overexpressing Advanced Cancer
NCT04982224 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-11-03
Summary
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)
Conditions
- Advanced NSCLC
Interventions
- DRUG
-
REGN5093-M114
Administered by intravenous (IV) infusion
- DRUG
-
Administered by IV infusion
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trial Management · Regeneron Pharmaceuticals
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-09
- Primary Completion
- 2025-10-15
- Completion
- 2025-10-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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