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RecruitingPhase 1NCT07403721

AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors

A Phase 1/1b Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AMG 436 as Monotherapy and in Combination With Other Therapies in Participants With Microsatellite Instability-high (MSI-H)/Mismatch Repair Deficient (dMMR) Solid Tumors

Sponsor

Amgen

Enrollment

464 participants

Start Date

Mar 23, 2026

Study Type

INTERVENTIONAL

Conditions

Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR)

Summary

The primary objectives of this trial are to evaluate the safety profile of AMG 436 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for AMG 436 as monotherapy and in combination with other anti-cancer therapies in participants with MSI-H/dMMR solid tumors.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria6

  • Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
  • Histologically confirmed MSI-H or dMMR metastatic or locally advanced solid tumor by local testing or central testing.
  • Tumor tissue (formalin-fixed, paraffin-embedded sample) archival block must be available. Participants without archived tumor tissue may enroll by undergoing tumor biopsy before dosing.
  • Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
  • Eastern Cooperative Oncology Group performance (ECOG) 0-1.
  • Adequate organ function as defined in the protocol.

Exclusion Criteria6

  • Participants with primary central nervous system (CNS) tumors.
  • Impaired cardiac function or clinically significant cardiac disease.
  • Major surgery within 28 days of trial day 1.
  • Antitumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 21 days of first dose of trial treatment, unless anti-tumor therapy is a therapy with 5 times the half-life being shorter than 21 days (in this case, enrollment may be allowed with washout from prior therapy of \< 21 days.
  • Radiation therapy within 28 days of the first dose of trial treatment (or local or focal radiotherapy with palliative intent within 14 days of the first dose).
  • Gastrointestinal tract disease causing the inability to take per os (PO) medication, malabsorption syndrome, requirement for intravenous (IV) alimentation, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).
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Interventions

DRUGAMG 436

AMG 436 will be administered.

Locations(2)

Next Oncology - Dallas

Irving, Texas, United States

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

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NCT07403721