Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Adult Patients With Mesenchymal Epithelial Transition Factor (MET) Overexpressing Advanced Cancer

Part of paid clinical trials in Orange, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT04982224
Phase
PHASE1
Status
Terminated

Conditions

  • Advanced NSCLC

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • REGN5093-M114 — DRUG
    Administered by intravenous (IV) infusion
  • Cemiplimab — DRUG
    Administered by IV infusion

Study Details

This study is researching an experimental drug called REGN5093-M114 by itself and in combination with cemiplimab. The study is focused on advanced non-small cell lung cancer (NSCLC) that produces too much of a protein called mesenchymal epithelial transition factor (MET) on the cancer cell surface. The aim of the study is to see how safe, tolerable, and effective the study drug is. This study will include 3 study groups, or cohorts, and each group is split into 2 parts: Part 1: The main purpose of part 1 is to determine a safe dose of REGN5093-M114 (Cohorts A and B), and in combination with cemiplimab (Cohort C). Part 2: The main purpose of part 2 is to use the REGN5093-M114 dose found for each cohort in part 1 to see how well the study drug works to shrink tumors. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drug * Does the study drug work to reduce or delay the progression of your cancer * How much study drug is in the blood at different times * Does the body make antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Key Dates

Start date
Nov 9, 2021
Status verified
Oct 2025
Primary completion
Oct 15, 2025
Completion
Oct 15, 2025

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1. Dose Escalation
    Cohorts A and B: REGN5093-M114 monotherapy. Cohort C: REGN5093-M114+cemiplimab combination.
  • Experimental: Phase 2. Dose Expansion
    Cohorts A and B: REGN5093-M114 monotherapy. Cohort C: REGN5093-M114+cemiplimab combination.

Primary Outcome Measure

Dose limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]

Locations (11)

FacilityCityStateZIPSite coordinators
University of California Irvine School of Medicine - Suite 400, Room 407OrangeCalifornia92868-
University of Colorado Hospital Anshutz Outpatient PavillionDenverColorado80045-
Johns Hopkins Hospital - Clinical Study Location - Skip Viragh Outpatient Cancer BuildingBaltimoreMaryland21231-
Sidney Kimmel Comprehensive Cancer Center - 4F Second Medical BuildingBaltimoreMaryland21231-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Henry Ford Hospital, Henry Ford Cancer InstituteDetroitMichigan48202-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of Pittsburgh Medical Center - Hillman Cancer CenterPittsburghPennsylvania15232-
MUSC Hollings Cancer CenterCharlestonSouth Carolina29425-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Next VirginiaFairfaxVirginia22031-

Find similar trials in Orange, CA

By research site
University of California Irvine School of Medicine - Suite 400, Room 407· Orange, CAUniversity of Colorado Hospital Anshutz Outpatient Pavillion· Denver, COJohns Hopkins Hospital - Clinical Study Location - Skip Viragh Outpatient Cancer Building· Baltimore, MDSidney Kimmel Comprehensive Cancer Center - 4F Second Medical Building· Baltimore, MDDana-Farber Cancer Institute· Boston, MAHenry Ford Hospital, Henry Ford Cancer Institute· Detroit, MI

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