A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer
Regeneron Pharmaceuticals
Summary
This study will evaluate REGN5093 for the treatment of Non-Small Cell Lung Cancer (NSCLC) with MET alteration. The main purpose of this study is to determine the safety, tolerability, and effectiveness of REGN5093. The study has two phases. The main goal of Phase 1 is to determine a safe dose(s) of REGN5093. The main goal of phase 2 of the study is to use the REGN5093 drug dose(s) found in Phase 1 to see how well REGN5093 works to shrink tumors. The study is looking at several other research questions, including: * Side effects that may be experienced by people taking REGN5093 * How REGN5093 works in the body * How much REGN5093 is present in the blood * To see if REGN5093 works to reduce or delay the progression of cancer * How long it takes REGN5093 to work in the body
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 Group (ECOG) performance status of 0 or 1 5. Adequate organ and bone marrow function as described in the protocol Key Exclusion Criteria: 1. Has received treatment with an approved systemic therapy or has participated in any study of an investigational agent or investigational device within 2 weeks…
Interventions
- DrugREGN5093
Intravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase.
Locations (40)
- University of Alabama at BirminghamBirmingham, Alabama
- University of California Irvine Medical Center - Bldg 56, RT81, Rm 241Orange, California
- Georgetown University Medical CenterWashington D.C., District of Columbia
- Moffitt Cancer Center - McKinley DriveTampa, Florida
- University of Kentucky, Markey Cancer Center Clinical Research OrganizationLexington, Kentucky
- DNU_Massachusetts General Hospital_DNUBoston, Massachusetts