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

Study Identifier:
R13089-ONC-25128
CT.gov Identifier:
NCT07863024
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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Study 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
Medical Condition
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.
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Melanoma
Renal
Gastric
Digestive & Intestinal
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 I/II
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
Inclusion criteria
  • 1. 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
  • 2. Participants must not be candidates for curative surgery or radiation
  • 3. 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
  • 4. Willing to provide tumor tissue; archival or fresh tumor tissue will be accepted as described in the protocol
  • 5. 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
  • 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • 7. Adequate organ and bone marrow function as described 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 as described in the protocol
  • 2. 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.
  • 3. Has undergone major surgery within the 14 days prior to first administration of study intervention
  • 4. Has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities resulting from prior therapy as described in the protocol
  • 5. 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.
  • 6. Has received prior treatment with an antibody-drug conjugate (ADC) that includes a topoisomerase payload
  • 7. 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

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Nehal Lakhani
Status
Will Be Recruiting
Condition(s) Treated at Site
Bowel (Colorectal)
Non-Small Cell Lung Cancer
Melanoma
Renal
Gastric
Digestive & Intestinal