drugset / Trial / NCT04982224

Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Adult Patients With Mesenchymal Epithelial Transition Factor (MET) Overexpressing Advanced Cancer

NCT04982224

Phase 1 Terminated 30 enrolled Regeneron Pharmaceuticals
Non-randomizedSequentialOpen-labelTreatment

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)

Timeline

Start
2021-11-09
Primary completion
2025-10-15
Completion
2025-10-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Cemiplimab Monoclonal antibody Intravenous
Subject REGN5093-M114 Unknown Intravenous