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

NCT07863024 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: R13089-ONC-25128
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief 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). 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. 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

Conditions

Advanced Solid Tumors

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; Uveal melanoma

Outcome Measures

Primary Outcomes (5)

• Occurrence of dose-limiting toxicities (DLTs)

  Part 1 (Dose Escalation)

  Up to 21 days

• Occurrence of Treatment Emergent Adverse Events (TEAEs)

  Part 1 (Dose Escalation)

  Up to approximately 5 years

• Occurrence of Serious Adverse Events (SAEs)

  Part 1 (Dose Escalation)

  Up to approximately 5 years

• Occurrence of adverse event of special interests (AESIs)

  Part 1 (Dose Escalation)

  Up to approximately 5 years

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

  Part 2 (Dose Expansion)

  Up to approximately 5 years

Secondary Outcomes (12)

• Objective response (investigator assessed) per RECIST 1.1

  Up to approximately 5 years

• Concentrations of ADC

  Up to approximately 5 years

• Concentrations of total antibody

  Up to approximately 5 years

• Concentrations of payload (ProDXd and DXd)

  Up to approximately 5 years

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

  Up to approximately 5 years

Study Arms (2)

Part 1: Dose Escalation

EXPERIMENTAL

Drug: REGN13089-M404-M2980

Part 2: Dose Expansion

EXPERIMENTAL

Drug: REGN13089-M404-M2980

Interventions

REGN13089-M404-M2980 DRUG

Administered per the protocol

Part 1: Dose Escalation; Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

MeSH Terms

Conditions

Carcinoma, Renal Cell; Colorectal Neoplasms; Stomach Neoplasms; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Uveal Melanoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Eye Diseases; Uveal Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1: Sequential assignment Part 2: Randomized assignment

Study Record Dates

• First Submitted: October 2, 2026
• First Posted: October 7, 2026
• Study Start (Estimated): November 23, 2026
• Primary Completion (Estimated): March 10, 2031
• Study Completion (Estimated): March 10, 2031
• Last Updated: October 7, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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
• 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