Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as davutamig
REGN5093 · 1 trial · 1 indication
Phase 1/Dose escalation
Phase 1/Dose escalation
Phase 1/Dose escalation
Phase 1/Dose escalation
Phase 1/Dose escalation
Phase 1/Dose escalation
Phase 2/Dose expansion
| Arm | Type | Description |
|---|---|---|
| REGN5093 | EXPERIMENTAL | Monotherapy in dose escalation cohorts (phase 1) followed by an expansion phase (phase 2) |
| Name | Type | Description |
|---|---|---|
| REGN5093 | DRUG | Intravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase. |
Key Inclusion Criteria: 1. Histologically confirmed advanced NSCLC that is unresectable or metastatic as described in the protocol 2. Willing to provide tumor tissue as described in the protocol 3. Documented presence of MET alteration as described in the protocol. 4. Eastern Cooperative Oncology G...
REGN5093 is an investigational therapy being studied for adults with MET-altered advanced non-small cell lung cancer (NSCLC). It is being evaluated in patients whose tumors show alterations in the MET gene. It has not been approved for any indication and remains in clinical development.
REGN5093 targets MET, also called mesenchymal epithelial transition factor, a protein involved in cell growth and survival. The program is biomarker-selected, meaning it is directed at patients whose advanced NSCLC tumors carry MET alterations. Targeting MET is intended to address the driver of tumor growth in this molecularly defined population.
REGN5093 is being developed by Regeneron Pharmaceuticals, Inc., which trades on Nasdaq under the ticker REGN. Regeneron is the sponsor of the clinical program evaluating the drug in MET-altered advanced non-small cell lung cancer. The asset is part of the company's oncology pipeline.
REGN5093 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory authority. The Phase 1 program is designed to evaluate the drug in adult patients with MET-altered advanced non-small cell lung cancer.
REGN5093 is being studied in one active clinical trial, NCT04077099, titled A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer. The Phase 1 trial has enrolled 95 patients across the United States, France, and South Korea and is currently active but not recruiting.
The REGN5093 Phase 1 trial, NCT04077099, enrolls adults aged 18 years and older of any sex with MET-altered advanced non-small cell lung cancer. It does not enroll healthy volunteers. The study is uncontrolled and open-label, with 95 patients enrolled across sites in the United States, France, and South Korea.