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RecruitingInterventionalPhase 1/Phase 2

A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer

NCT ID: NCT04077099Sponsor: Regeneron PharmaceuticalsLast updated: 2026-06-17

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

Arms & interventions

  • DrugREGN5093

    Intravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase.

Outcome measures

Primary

  • Number of patients with Dose Limiting Toxicities (DLTs)

    Phase 1/Dose escalation

    Time frame: Up to 21 days

  • Incidence and severity of treatment-emergent adverse events (TEAEs)

    Phase 1/Dose escalation

    Time frame: Through study completion, an average of 12 years

  • Incidence and severity of adverse events of special interest (AESIs)

    Phase 1/Dose escalation

    Time frame: Through study completion, an average of 12 years

  • Incidence and severity of serious adverse events (SAEs)

    Phase 1/Dose escalation

    Time frame: Through study completion, an average of 12 years

  • Incidence and severity of grade ≥3 laboratory abnormalities

    Phase 1/Dose escalation

    Time frame: Through study completion, an average of 12 years

  • REGN5093 concentrations in serum over time

    Phase 1/Dose escalation

    Time frame: Through study completion, an average of 12 years

  • Objective response rate (ORR) per RECIST 1.1

    Phase 2/Dose expansion

    Time frame: Through study completion, an average of 12 years

Secondary

  • ORR per RECIST 1.1

    Time frame: Through study completion, an average of 12 years

  • Incidence and severity of TEAEs

    Time frame: Through study completion, an average of 12 years

  • Incidence and severity of AESIs

    Time frame: Through study completion, an average of 12 years

  • Incidence and severity of SAEs

    Time frame: Through study completion, an average of 12 years

  • Incidence and severity of grade ≥3 laboratory abnormalities

    Time frame: Through study completion, an average of 12 years

  • REGN5093 Pharmacokinetics (PK)

    Time frame: Through study completion, an average of 12 years

  • REGN5093 concentrations in serum over time

    Time frame: Through study completion, an average of 12 years

  • Duration of response (DOR) per RECIST 1.1.

    Time frame: Through study completion, an average of 12 years

  • Disease control rate (DCR) per RECIST 1.1.

    Time frame: Through study completion, an average of 12 years

  • Progression free survival (PFS) per RECIST 1.1.

    Time frame: Through study completion, an average of 12 years

  • Overall survival (OS)

    Time frame: Through study completion, an average of 12 years

  • Time to response (TTR) per RECIST 1.1

    Time frame: Through study completion, an average of 12 years

  • Incidence of anti-drug antibodies (ADA) to REGN5093

    Time frame: Through study completion, an average of 12 years

  • Titer of ADA to REGN5093

    Time frame: Through study completion, an average of 12 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 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

Study locations (18)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

Withdrawn

University of California Irvine Medical Center - Bldg 56, RT81, Rm 241

Orange, California, 92868

Completed

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007

Completed

Moffitt Cancer Center - McKinley Drive

Tampa, Florida, 33612

Recruiting

University of Kentucky, Markey Cancer Center Clinical Research Organization

Lexington, Kentucky, 40536

Withdrawn

DNU_Massachusetts General Hospital_DNU

Boston, Massachusetts, 02114

Withdrawn

Dana Farber Harvard Cancer Center Consortium

Boston, Massachusetts, 02215

Completed

Henry Ford Health System

Detroit, Michigan, 48202

Withdrawn

Washington University School of Medicine

St Louis, Missouri, 63110

Withdrawn

NYU Cancer Institute

New York, New York, 10016

Withdrawn

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Completed

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Completed

Duke Cancer Center

Durham, North Carolina, 27710

Withdrawn

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104

Withdrawn

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

Withdrawn

University of Pittsburgh UPMC - Clinical Research Services

Pittsburgh, Pennsylvania, 15232

Completed

Harold C. Simmons Comprehensive Cancer Center

Dallas, Texas, 75235

Withdrawn

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting