A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer
Sponsor: Regeneron Pharmaceuticals
ClinicalTrials ID:NCT04077099
This study assesses the safety, tolerability, and efficacy of REGN5093 in advanced NSCLC with MET alteration. Phase 1 identifies safe dosing, while Phase 2 evaluates tumor response. Eligibility includes confirmed advanced NSCLC, MET alteration, ECOG status 0-1, and adequate organ function. REGN5093 is administered via IV infusion with dose escalation and expansion phases.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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 Criteria
Inclusion Criteria
- Histologically confirmed advanced NSCLC that is unresectable or metastatic as described in the protocol
- Willing to provide tumor tissue as described in the protocol
- Documented presence of MET alteration as described in the protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function as described in the protocol
Key
Exclusion Criteria
- Has received treatment with an approved systemic therapy or has participated in any study of an investigational agent or investigational device within 2 weeks as described in the protocol
- Has not yet recovered from any acute toxicities resulting from prior therapy with certain exceptions as described in the protocol
- Has received radiation therapy or major surgery within 14 days as described in the protocol
- Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease or spinal cord compression as defined in the protocol
- Uncontrolled infection as described in the protocol
Note: Other protocol defined Inclusion/Exclusion criteria apply
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham | 35294 | Birmingham | Alabama |
| University of California Irvine Medical Center - Bldg 56, RT81, Rm 241 | 92868 | Orange | California |
| Georgetown University Hospital | 20007 | Washington D.C. | District of Columbia |
| Moffitt Cancer Center - McKinley Drive | 33612 | Tampa | Florida |
| University of Kentucky, Markey Cancer Center Clinical Research Organization | 40536 | Lexington | Kentucky |
| DNU_Massachusetts General Hospital_DNU | 02114 | Boston | Massachusetts |
| Dana Farber Harvard Cancer Center Consortium | 02215 | Boston | Massachusetts |
| Henry Ford Health System | 48202 | Detroit | Michigan |
| Washington University School of Medicine | 63110 | St Louis | Missouri |
| NYU Cancer Institute | 10016 | New York | New York |
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