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

October 30, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The trial was intended to be a Phase 1/2 trial, but no participants were enrolled in Phase 2

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • University of California Irvine School of Medicine - Suite 400, Room 407
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado Hospital Anshutz Outpatient Pavillion
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins Hospital - Clinical Study Location - Skip Viragh Outpatient Cancer Building
      • Baltimore, Maryland, United States, 21231
        • Sidney Kimmel Comprehensive Cancer Center - 4F Second Medical Building
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital, Henry Ford Cancer Institute
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center - Hillman Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC Hollings Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • NEXT Virginia

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regeneron Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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 or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • 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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