RecruitingPhase 1 / Phase 2NCT04077099

A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer

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

Checked against the public recordLast updated Jun 17, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 1 / Phase 2
U.S. locations40
SponsorRegeneron Pharmaceuticals
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Regeneron Pharmaceuticals
Interventions being studied
Drug: REGN5093
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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 as described in the protocol 2. Has not yet recovered from any acute toxicities resulting from prior therapy with certain exceptions as described in the protocol 3. Has received radiation therapy or major surgery within 14 days as described in the protocol 4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease or spinal cord compression as defined in the protocol 5. Uncontrolled infection as described in the protocol Note: Other protocol defined Inclusion/Exclusion criteria apply

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • 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
  • Dana Farber Harvard Cancer Center ConsortiumBoston, Massachusetts
  • Henry Ford Health SystemDetroit, Michigan
  • Washington University School of MedicineSt Louis, Missouri
  • NYU Cancer InstituteNew York, New York
  • Icahn School of Medicine at Mount SinaiNew York, New York
  • Memorial Sloan Kettering Cancer CenterNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 17, 2026. Always confirm current availability with the study team.

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