A Study of REGN5093 for MET-Altered Advanced Non-Small Cell Lung Cancer
This study is testing a drug called REGN5093 for adults with advanced non-small cell lung cancer (NSCLC) that has a specific change called a MET alteration. The main goals are to find a safe dose of REGN5093 and then see how well it works to shrink tumors. Researchers will also look at any side effects you might experience and how the drug works in your body. To join, you must have advanced NSCLC that is unresectable (cannot be removed by surgery) or has spread, and your cancer must have a MET alteration. You will also need to provide a tumor tissue sample. The study aims to enroll 231 participants.
- Study design
- This study has two phases: Phase 1 to find a safe dose, and Phase 2 to see how well the drug shrinks tumors. It is an interventional study, meaning participants will receive the study drug.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for adverse events (side effects) through study completion, which is an average of 12 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer
At a glance
Conditions
Where it's being run
40 sites across 24 statesStudy leadership
- Clinical Trial Management · STUDY_DIRECTOR · Regeneron Pharmaceuticals
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Number of patients with Dose Limiting Toxicities (DLTs)Up to 21 days
Phase 1/Dose escalation
- Incidence and severity of treatment-emergent adverse events (TEAEs)Through study completion, an average of 12 years
Phase 1/Dose escalation
- Incidence and severity of adverse events of special interest (AESIs)Through study completion, an average of 12 years
Phase 1/Dose escalation
- Incidence and severity of serious adverse events (SAEs)Through study completion, an average of 12 years
Phase 1/Dose escalation
- Incidence and severity of grade ≥3 laboratory abnormalitiesThrough study completion, an average of 12 years
Phase 1/Dose escalation
- REGN5093 concentrations in serum over timeThrough study completion, an average of 12 years
Phase 1/Dose escalation
- Objective response rate (ORR) per RECIST 1.1Through study completion, an average of 12 years
Phase 2/Dose expansion