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

April 17, 2024 updated by: Regeneron Pharmaceuticals

A Phase 1/2 Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Patients With MET Overexpressing Advanced Cancer

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

237

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92617
        • Recruiting
        • University of California Irvine Medical Center (UCIMC)
        • Contact:
        • Principal Investigator:
          • Sai-Hong I Ou
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Recruiting
        • John Hopkins
        • Contact:
      • Baltimore, Maryland, United States, 21231
        • Recruiting
        • Johns Hopkins Satellite Site
        • Contact:
        • Principal Investigator:
          • Patrick Forde, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Principal Investigator:
          • Shirish Gadgeel
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
        • Principal Investigator:
          • Alexander Drillon
      • New York, New York, United States, 10012
        • Withdrawn
        • NYU Langone Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Medical Center - Hillman Cancer Center
        • Contact:
        • Principal Investigator:
          • Liza Villaruz
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Withdrawn
        • Medical University of South Carolina (MUSC)
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Md Anderson Cancer Center
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specilaist
        • Principal Investigator:
          • Alexander Spira, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Histologically confirmed NSCLC that is at advanced stage for which there are no approved therapies available expected to confer clinical benefit as defined in the protocol
  2. Willing to provide tumor tissue from newly obtained biopsy from tumor site. Newly obtained biopsies at tissue screening are required. An archival sample can be accepted only after discussion with the medical monitor and if the sample is not more than 6 months old and was obtained on the treatment regimen prior to study screening or after completion of the last therapy. The enrollment of patients will be based on an immunohistochemistry (IHC)-based assay using freshly obtained tumor biopsies or an archival biopsy as described above. Only patients with MET overexpressing tumors by central IHC analysis will be enrolled. For expansion cohorts only: tumor site for biopsy must not have been irradiated previously and must not be the only measurable lesion.
  3. Tumor must overexpress MET protein as defined in the protocol
  4. For expansion only: At least one lesion that is measurable by RECIST 1.1. Tumor lesions in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions after radiation.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. Adequate organ and bone marrow function as defined 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 or 5 half-lives of the prior treatment, whichever is shorter with a minimum of 7 days from the first dose of study therapy
  2. Has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities resulting from prior therapy except as described in the protocol
  3. Has received radiation therapy or major surgery within 14 days of first administration of study drug or has not recovered from adverse events as defined in the protocol
  4. Another malignancy that is progressing or requires active treatment except as noted in the protocol
  5. Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol
  6. Encephalitis, meningitis, organic brain disease (eg Parkinson's disease) or uncontrolled seizures in the year prior to first dose of study therapy
  7. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency as defined in the protocol

NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1. Dose Escalation
Cohorts A and B: REGN5093-M114 monotherapy. Cohort C: REGN5093-M114+cemiplimab combination.
Drug: Cemiplimab
Administered by IV infusion
Drug: REGN5093-M114
Administered by intravenous (IV) infusion
Experimental: Phase 2. Dose Expansion
Cohorts A and B: REGN5093-M114 monotherapy. Cohort C: REGN5093-M114+cemiplimab combination.
Drug: Cemiplimab
Administered by IV infusion
Drug: REGN5093-M114
Administered by intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose limiting toxicities (DLTs)
Time Frame: Up to 28 days
Dose escalation (Phase 1)
Up to 28 days
Treatment-emergent adverse events (TEAEs)
Time Frame: Through study completion, an average of 2 years
Dose escalation (Phase 1)
Through study completion, an average of 2 years
Serious adverse events (SAEs)
Time Frame: Through study completion, an average of 2 years
Dose escalation (Phase 1)
Through study completion, an average of 2 years
Laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE])
Time Frame: Through study completion, an average of 2 years
Dose escalation (Phase 1)
Through study completion, an average of 2 years
Concentrations of REGN5093-M114 in serum
Time Frame: Through study completion, an average of 2 years
Dose escalation (Phase 1)
Through study completion, an average of 2 years
Total monoclonal antibodies (REGN5093- M114 plus unconjugated antibody) in serum
Time Frame: Through study completion, an average of 2 years
Dose escalation (Phase 1)
Through study completion, an average of 2 years
Concentrations of M24 in plasma
Time Frame: Through study completion, an average of 2 years
Dose escalation (Phase 1)
Through study completion, an average of 2 years
Objective response rate (ORR)
Time Frame: Through study completion, an average of 2 years
Dose expansion (Phase 2)
Through study completion, an average of 2 years
TEAEs leading to study treatment discontinuation
Time Frame: Through study completion, an average of 2 years
Dose escalation (Phase 1)
Through study completion, an average of 2 years
TEAEs leading to death
Time Frame: Through study completion, an average of 2 years
Dose escalation (Phase 1)
Through study completion, an average of 2 years
Concentrations of cemiplimab when given in combination with REGN5093-M114
Time Frame: Through study completion, an average of 2 years
Dose escalation (Phase 1) Cohort C
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: Through study completion, an average of 2 years
Dose escalation (Phase 1)
Through study completion, an average of 2 years
TEAEs
Time Frame: Through study completion, an average of 2 years
Dose expansion (Phase 2)
Through study completion, an average of 2 years
SAEs
Time Frame: Through study completion, an average of 2 years
Dose expansion (Phase 2)
Through study completion, an average of 2 years
Laboratory abnormalities (grade 3 or higher per CTCAE)
Time Frame: Through study completion, an average of 2 years
Dose expansion (Phase 2)
Through study completion, an average of 2 years
Concentrations of REGN5093-M114 in serum
Time Frame: Through study completion, an average of 2 years
Dose expansion (Phase 2)
Through study completion, an average of 2 years
Total monoclonal antibodies (REGN5093- M114 plus unconjugated antibody) in serum
Time Frame: Through study completion, an average of 2 years
Dose expansion (Phase 2)
Through study completion, an average of 2 years
Concentrations of M24 in plasma
Time Frame: Through study completion, an average of 2 years
Dose expansion (Phase 2)
Through study completion, an average of 2 years
Duration of response (DOR)
Time Frame: Through study completion, an average of 2 years
Phase 1 and Phase 2
Through study completion, an average of 2 years
Disease control rate (DCR)
Time Frame: Through study completion, an average of 2 years
Phase 1 and Phase 2
Through study completion, an average of 2 years
Time to tumor response (TTR)
Time Frame: Through study completion, an average of 2 years
Phase 1 and Phase 2
Through study completion, an average of 2 years
Progression free survival (PFS)
Time Frame: Through study completion, an average of 2 years
Phase 1 and Phase 2
Through study completion, an average of 2 years
Overall survival (OS)
Time Frame: Through study completion, an average of 2 years
Phase 1 and Phase 2
Through study completion, an average of 2 years
TEAEs leading to study treatment discontinuation
Time Frame: Through study completion, an average of 2 years
Dose expansion (Phase 2)
Through study completion, an average of 2 years
TEAEs leading to death
Time Frame: Through study completion, an average of 2 years
Dose expansion (Phase 2)
Through study completion, an average of 2 years
Concentrations of cemiplimab when given in combination with REGN5093-M114
Time Frame: Through study completion, an average of 2 years
Dose expansion (Phase 2) Cohort C
Through study completion, an average of 2 years
Incidence of Anti-drug antibodies (ADA) against cemiplimab over time, when given in combination with REGN5093-M114
Time Frame: Through study completion, an average of 2 years
Dose expansion (Phase 2) Cohort C
Through study completion, an average of 2 years
Titer of ADA against cemiplimab over time, when given in combination with REGN5093-M114
Time Frame: Through study completion, an average of 2 years
Dose expansion (Phase 2) Cohort C
Through study completion, an average of 2 years
Incidence of ADA to REGN5093-M114 over time in monotherapy
Time Frame: Through study completion, an average of 2 years
Phase 1 and Phase 2
Through study completion, an average of 2 years
Titer of ADA to REGN5093-M114 over time in monotherapy
Time Frame: Through study completion, an average of 2 years
Phase 1 and Phase 2
Through study completion, an average of 2 years
Incidence of ADA to REGN5093-M114 over time in combination with cemiplimab
Time Frame: Through study completion, an average of 2 years
Phase 1 and Phase 2
Through study completion, an average of 2 years
Titer of ADA to REGN5093-M114 over time in combination with cemiplimab
Time Frame: Through study completion, an average of 2 years
Phase 1 and Phase 2
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2021

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

February 1, 2030

Study Registration Dates

First Submitted

July 20, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (Actual)

July 29, 2021

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R5093-M114-ONC-1864
  • 2020-005065-14 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD Sharing Time Frame

When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.

IPD Sharing Access Criteria

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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