Stopped: Sponsor decision
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)
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Dose limiting toxicities (DLTs)
Timeframe: Up to 28 days
Treatment-emergent adverse events (TEAEs)
Timeframe: Through study completion, an average of 2 years
Serious adverse events (SAEs)
Timeframe: Through study completion, an average of 2 years
TEAEs leading to study treatment discontinuation
Timeframe: Through study completion, an average of 2 years
TEAEs leading to death
Timeframe: Through study completion, an average of 2 years
Laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE])
Timeframe: Through study completion, an average of 2 years
Concentrations of REGN5093-M114 in serum
Timeframe: Through study completion, an average of 2 years
Total monoclonal antibodies (REGN5093- M114 plus unconjugated antibody) in serum
Timeframe: Through study completion, an average of 2 years
Concentrations of M24 in plasma
Timeframe: Through study completion, an average of 2 years
Concentrations of cemiplimab when given in combination with REGN5093-M114
Timeframe: Through study completion, an average of 2 years
Objective response rate (ORR)
Timeframe: Through study completion, an average of 2 years