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Advanced Solid TumorsPhase 1/2NCT07863024

Safety and Efficacy Study in Adults With Advanced Solid Tumors Receiving REGN13089-M404-M2980, an Antibody-drug Conjugate That Targets MET Protein on Tumors

A Phase 1/2 study testing REGN13089-M404-M2980 in people with Advanced Solid Tumors, run by Regeneron Pharmaceuticals.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study will test a Regeneron drug called REGN13089-M404-M2980 ("study drug") to see if it can help treat previously treated, advanced solid tumors (tumors that have grown and spread to different areas of the body). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
REGN13089-M404-M2980
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
No sites listed yet
Study dates
23 Nov 2026to 10 Mar 2031
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 cancer (non-small cell lung cancer (epidermal growth factor receptor mutant type or epidermal growth factor receptor mutant type), colorectal cancer, gastric/gastroesophageal junction cancer, uveal melanoma, papillary renal cell carcinoma, or clear cell renal cell carcinoma) that is at an advanced stage as described in the protocol
  • Participants must not be candidates for curative surgery or radiation
  • Participants are required to have exhausted all therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease, or intolerance of the therapy as described in the protocol
  • Willing to provide tumor tissue; archival or fresh tumor tissue will be accepted as described in the protocol
  • At least 1 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 described 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 as described in the protocol
  • Has received radiation therapy within the 28 days prior to first administration of study intervention. Palliative stereotactic radiation therapy without a thoracic or abdominal field is allowed with a washout period of 14 days from first administration of study intervention.
  • Has undergone major surgery within the 14 days prior to first administration of study intervention
  • Has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities resulting from prior therapy as described in the protocol
  • Has a history of interstitial lung disease (eg, idiopathic pulmonary fibrosis, etc) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management or has imaging consistent with these diseases during the screening period. A history of radiation pneumonitis is permitted as long as pneumonitis resolved ≥6 months prior to enrollment.
  • Has received prior treatment with an antibody-drug conjugate (ADC) that includes a topoisomerase payload
  • Known active or untreated brain metastases or spinal cord compression. Participants are eligible if central nervous system (CNS) metastases are adequately treated, and participants have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment.
  • Note: Other protocol defined inclusion/ exclusion criteria apply

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Clinical Trials Administrator contact

844-734-6643

clinicaltrials@regeneron.com

About this study

Official title: A Phase 1/2 Study of REGN13089-M404-M2980, a MET-targeting Antibody-Drug Conjugate in Adult Participants With Previously Treated Advanced Solid Tumors

This study will test a Regeneron drug called REGN13089-M404-M2980 ("study drug") to see if it can help treat previously treated, advanced solid tumors (tumors that have grown and spread to different areas of the body).

The study is focused on advanced cancers that have more of a protein called mesenchymal epithelial transition factor (MET) on the surface of their cells than usual. The study drug works by binding to MET on tumor cells and delivering chemotherapy directly into those cells. This may stop growth of the cancer cells and kill only the cancer cells and not the other normal tissues in your body. However, some of the chemotherapy may still affect the normal cells and side effects can still occur.

Read more

The study is looking at:

  • What side effects the study drug might cause
  • How well the study drug works
  • How much of the study drug is in the blood at different times
  • If the body reacts to the study drug, in a way that may cause the study drug to not work as well
  • What is the best dose of the study drug for treating previously treated, advanced solid tumors
Being tested
REGN13089-M404-M2980
Keywords
ADC, Antibody-drug conjugate, Advanced cancer, Advanced solid malignancy, Clear cell renal cell carcinoma, Colorectal cancer, First-in-human, FIH, Gastric cancer, Gastroesophageal junction cancer, MET, METxMET antibody-drug conjugate, Metastatic, Metastatic solid tumor, Non-small cell lung cancer, NSCLC, Papillary renal cell carcinoma, Solid neoplasm, Unresectable, Unresectable solid tumor
Medical subject headings
Carcinoma, Renal Cell, Colorectal Neoplasms, Stomach Neoplasms, Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Uveal Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REGN13089-M404-M2980Drug

    Administered per the protocol

Study groups in NCT07863024
Study groupRoleWhat they receive
Part 1: Dose EscalationExperimentalNot described
Receives: Drug: REGN13089-M404-M2980
Part 2: Dose ExpansionExperimentalNot described
Receives: Drug: REGN13089-M404-M2980

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of dose-limiting toxicities (DLTs)

    Part 1 (Dose Escalation)

    Measured: Up to 21 days

  2. Occurrence of Treatment Emergent Adverse Events (TEAEs)

    Part 1 (Dose Escalation)

    Measured: Up to approximately 5 years

  3. Occurrence of Serious Adverse Events (SAEs)

    Part 1 (Dose Escalation)

    Measured: Up to approximately 5 years

  4. Occurrence of adverse event of special interests (AESIs)

    Part 1 (Dose Escalation)

    Measured: Up to approximately 5 years

  5. Objective response (OR) (investigator assessed) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

    Part 2 (Dose Expansion)

    Measured: Up to approximately 5 years

Secondary outcomes (12)

  1. Objective response (investigator assessed) per RECIST 1.1

    Part 1 (Dose Escalation)

    Measured: Up to approximately 5 years

  2. Concentrations of ADC

    Part 1 (Dose Escalation) and Part 2 (Dose Expansion)

    Measured: Up to approximately 5 years

  3. Concentrations of total antibody

    Part 1 (Dose Escalation) and Part 2 (Dose Expansion)

    Measured: Up to approximately 5 years

  4. Concentrations of payload (ProDXd and DXd)

    Part 1 (Dose Escalation) and Part 2 (Dose Expansion)

    Measured: Up to approximately 5 years

  5. Occurrence of Anti-Drug Antibodies (ADA) against REGN13089-M404-M2980

    Part 1 (Dose Escalation) and Part 2 (Dose Expansion)

    Measured: Up to approximately 5 years

  6. Magnitude of ADA against REGN13089-M404-M2980

    Part 1 (Dose Escalation) and Part 2 (Dose Expansion)

    Measured: Up to approximately 5 years

  7. Duration of response per RECIST 1.1

    Part 2 (Dose Expansion)

    Measured: Up to approximately 5 years

  8. Time to response per RECIST 1.1

    Part 2 (Dose Expansion)

    Measured: Up to approximately 5 years

  9. Progression-free survival per RECIST 1.1

    Part 2 (Dose Expansion)

    Measured: Up to approximately 5 years

  10. Overall survival

    Part 2 (Dose Expansion)

    Measured: Up to approximately 5 years

  11. Occurrence of TEAEs considered clinically significant

    Part 2 (Dose Expansion)

    Measured: Up to approximately 5 years

  12. Laboratory abnormalities considered clinically significant

    Part 2 (Dose Expansion)

    Measured: Up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2026
  2. Study start23 Nov 2026 (estimated)
  3. Primary completion10 Mar 2031 (estimated)
  4. Study completion10 Mar 2031 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Part 1: Sequential assignment Part 2: Randomized assignment
Masking
None (open label)
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07863024
Sponsor's protocol ID
R13089-ONC-25128
Status last verified
Oct 2026
First submitted
2 Oct 2026
Last updated
7 Oct 2026
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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing REGN13089-M404-M2980 in people with Advanced Solid Tumors, run by Regeneron Pharmaceuticals.

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 7 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: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of dose-limiting toxicities (DLTs) (time frame: Up to 21 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07863024.

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 7 Oct 2026.

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Clinical Trial NCT07863024 | AzTrials