Advanced NSCLCPhase 1NCT04982224
Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Adult Patients With Mesenchymal Epithelial Transition Factor (MET) Overexpressing Advanced Cancer
A Phase 1 study testing REGN5093-M114 and Cemiplimab in people with Advanced NSCLC, run by Regeneron Pharmaceuticals at 11 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced NSCLC
- What is being tested?
- REGN5093-M114 and Cemiplimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 11 sitesUnited States
- Study dates
- 9 Nov 2021to 15 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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.
- Tumor must overexpress MET protein as defined in the protocol
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and bone marrow function as defined in the protocol
Who cannot join
- 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
- Has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities resulting from prior therapy except as described in the protocol
- 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
- Another malignancy that is progressing or requires active treatment except as noted in the protocol
- Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol
- Encephalitis, meningitis, organic brain disease (eg Parkinson's disease) or uncontrolled seizures in the year prior to first dose of study therapy
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Johns Hopkins Hospital - Clinical Study Location - Skip Viragh Outpatient Cancer Building
Baltimore, Maryland, 21231
Sidney Kimmel Comprehensive Cancer Center - 4F Second Medical Building
Baltimore, Maryland, 21231
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
MUSC Hollings Cancer Center
Charleston, South Carolina, 29425
University of Colorado Hospital Anshutz Outpatient Pavillion
Denver, Colorado, 80045
Henry Ford Hospital, Henry Ford Cancer Institute
Detroit, Michigan, 48202
Next Virginia
Fairfax, Virginia, 22031
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of California Irvine School of Medicine - Suite 400, Room 407
Orange, California, 92868
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: 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).
Read more
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)
Read the detailed description
The trial was intended to be a Phase 1/2 trial, but no participants were enrolled in Phase 2
- Conditions
- Advanced NSCLC
- Being tested
- REGN5093-M114, Cemiplimab
- Keywords
- Non-small cell lung cancer, Mesenchymal epithelial transition factor (MET), MET Overexpressing Advanced Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN5093-M114Drug
Administered by intravenous (IV) infusion
CemiplimabDrug
Administered by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Phase 1. Dose Escalation | Experimental | Cohorts A and B: REGN5093-M114 monotherapy. Cohort C: REGN5093-M114+cemiplimab combination. Receives: Drug: REGN5093-M114; Drug: Cemiplimab |
| Phase 2. Dose Expansion | Experimental | Cohorts A and B: REGN5093-M114 monotherapy. Cohort C: REGN5093-M114+cemiplimab combination. Receives: Drug: REGN5093-M114; Drug: Cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicities (DLTs)
Dose escalation (Phase 1)
Measured: Up to 28 days
Treatment-emergent adverse events (TEAEs)
Dose escalation (Phase 1)
Measured: Through study completion, an average of 2 years
Serious adverse events (SAEs)
Dose escalation (Phase 1)
Measured: Through study completion, an average of 2 years
TEAEs leading to study treatment discontinuation
Dose escalation (Phase 1)
Measured: Through study completion, an average of 2 years
TEAEs leading to death
Dose escalation (Phase 1)
Measured: Through study completion, an average of 2 years
Laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE])
Dose escalation (Phase 1)
Measured: Through study completion, an average of 2 years
Concentrations of REGN5093-M114 in serum
Dose escalation (Phase 1)
Measured: Through study completion, an average of 2 years
Total monoclonal antibodies (REGN5093- M114 plus unconjugated antibody) in serum
Dose escalation (Phase 1)
Measured: Through study completion, an average of 2 years
Concentrations of M24 in plasma
Dose escalation (Phase 1)
Measured: Through study completion, an average of 2 years
Concentrations of cemiplimab when given in combination with REGN5093-M114
Dose escalation (Phase 1) Cohort C
Measured: Through study completion, an average of 2 years
Objective response rate (ORR)
Dose expansion (Phase 2)
Measured: Through study completion, an average of 2 years
Secondary outcomes (21)
ORR
Dose escalation (Phase 1)
Measured: Through study completion, an average of 2 years
TEAEs
Dose expansion (Phase 2)
Measured: Through study completion, an average of 2 years
SAEs
Dose expansion (Phase 2)
Measured: Through study completion, an average of 2 years
TEAEs leading to study treatment discontinuation
Dose expansion (Phase 2)
Measured: Through study completion, an average of 2 years
TEAEs leading to death
Dose expansion (Phase 2)
Measured: Through study completion, an average of 2 years
Laboratory abnormalities (grade 3 or higher per CTCAE)
Dose expansion (Phase 2)
Measured: Through study completion, an average of 2 years
Concentrations of REGN5093-M114 in serum
Dose expansion (Phase 2)
Measured: Through study completion, an average of 2 years
Total monoclonal antibodies (REGN5093- M114 plus unconjugated antibody) in serum
Dose expansion (Phase 2)
Measured: Through study completion, an average of 2 years
Concentrations of M24 in plasma
Dose expansion (Phase 2)
Measured: Through study completion, an average of 2 years
Concentrations of cemiplimab when given in combination with REGN5093-M114
Dose expansion (Phase 2) Cohort C
Measured: 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
Dose expansion (Phase 2) Cohort C
Measured: Through study completion, an average of 2 years
Titer of ADA against cemiplimab over time, when given in combination with REGN5093-M114
Dose expansion (Phase 2) Cohort C
Measured: Through study completion, an average of 2 years
Duration of response (DOR)
Phase 1 and Phase 2
Measured: Through study completion, an average of 2 years
Disease control rate (DCR)
Phase 1 and Phase 2
Measured: Through study completion, an average of 2 years
Time to tumor response (TTR)
Phase 1 and Phase 2
Measured: Through study completion, an average of 2 years
Progression free survival (PFS)
Phase 1 and Phase 2
Measured: Through study completion, an average of 2 years
Overall survival (OS)
Phase 1 and Phase 2
Measured: Through study completion, an average of 2 years
Incidence of ADA to REGN5093-M114 over time in monotherapy
Phase 1 and Phase 2
Measured: Through study completion, an average of 2 years
Titer of ADA to REGN5093-M114 over time in monotherapy
Phase 1 and Phase 2
Measured: Through study completion, an average of 2 years
Incidence of ADA to REGN5093-M114 over time in combination with cemiplimab
Phase 1 and Phase 2
Measured: Through study completion, an average of 2 years
Titer of ADA to REGN5093-M114 over time in combination with cemiplimab
Phase 1 and Phase 2
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start9 Nov 2021
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced NSCLCStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982224
- Sponsor's protocol ID
- R5093-M114-ONC-1864
- Other IDs
- 2020-005065-14
- Status last verified
- Oct 2025
- First submitted
- 20 Jul 2021
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of REGN5093-M114 (METxMET Antibody-Drug Conjugate) in Patients With MET Overexpressing Advanced Cancer
- ClinicalTrials.gov ID
- NCT04982224
- Acronym / sponsor ID
- R5093-M114-ONC-1864
- Conditions
- Advanced NSCLC
- Keywords
- Non-small cell lung cancer, Mesenchymal epithelial transition factor (MET), MET Overexpressing Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
The trial was intended to be a Phase 1/2 trial, but no participants were enrolled in Phase 2
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1. Dose Escalation | Experimental | Drug: REGN5093-M114, Drug: CemiplimabCohorts A and B: REGN5093-M114 monotherapy. Cohort C: REGN5093-M114+cemiplimab combination. |
| Phase 2. Dose Expansion | Experimental | Drug: REGN5093-M114, Drug: CemiplimabCohorts A and B: REGN5093-M114 monotherapy. Cohort C: REGN5093-M114+cemiplimab combination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- 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.
- Tumor must overexpress MET protein as defined in the protocol
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (8 listed)
- 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
- Has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities resulting from prior therapy except as described in the protocol
- 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
- Another malignancy that is progressing or requires active treatment except as noted in the protocol
- Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression as defined in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN5093-M114Administered by intravenous (IV) infusion | Drug | Phase 1. Dose Escalation, Phase 2. Dose Expansion |
| CemiplimabAdministered by IV infusion | Drug | Phase 1. Dose Escalation, Phase 2. Dose Expansion |
Primary outcome
Dose limiting toxicities (DLTs)
Time frame: Up to 28 days
Dose escalation (Phase 1)
Treatment-emergent adverse events (TEAEs)
Time frame: Through study completion, an average of 2 years
Dose escalation (Phase 1)
Serious adverse events (SAEs)
Time frame: Through study completion, an average of 2 years
Dose escalation (Phase 1)
TEAEs leading to study treatment discontinuation
Time frame: Through study completion, an average of 2 years
Dose escalation (Phase 1)
TEAEs leading to death
Time frame: Through study completion, an average of 2 years
Dose escalation (Phase 1)
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)
Concentrations of REGN5093-M114 in serum
Time frame: Through study completion, an average of 2 years
Dose escalation (Phase 1)
Total monoclonal antibodies (REGN5093- M114 plus unconjugated antibody) in serum
Time frame: Through study completion, an average of 2 years
Dose escalation (Phase 1)
Concentrations of M24 in plasma
Time frame: Through study completion, an average of 2 years
Dose escalation (Phase 1)
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
Objective response rate (ORR)
Time frame: Through study completion, an average of 2 years
Dose expansion (Phase 2)
21 secondary outcomes
ORR
Time frame: Through study completion, an average of 2 years
TEAEs
Time frame: Through study completion, an average of 2 years
SAEs
Time frame: Through study completion, an average of 2 years
TEAEs leading to study treatment discontinuation
Time frame: Through study completion, an average of 2 years
TEAEs leading to death
Time frame: 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
Concentrations of REGN5093-M114 in serum
Time frame: 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
Concentrations of M24 in plasma
Time frame: 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
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
Titer of ADA against cemiplimab over time, when given in combination with REGN5093-M114
Time frame: Through study completion, an average of 2 years
Duration of response (DOR)
Time frame: Through study completion, an average of 2 years
Disease control rate (DCR)
Time frame: Through study completion, an average of 2 years
Time to tumor response (TTR)
Time frame: Through study completion, an average of 2 years
Progression free survival (PFS)
Time frame: Through study completion, an average of 2 years
Overall survival (OS)
Time frame: 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
Titer of ADA to REGN5093-M114 over time in monotherapy
Time frame: 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
Titer of ADA to REGN5093-M114 over time in combination with cemiplimab
Time frame: Through study completion, an average of 2 years
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing REGN5093-M114 and Cemiplimab in people with Advanced NSCLC, run by Regeneron Pharmaceuticals at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicities (DLTs) (time frame: Up to 28 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.