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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
Who can join
Ages 18 to 99 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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).
About the study
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.
What is being tested
- AMG 436 (drug)
Sponsor: Amgen · Participants: 464 · Started: Apr 8, 2026
Contact the study team
- Amgen Call Center · Phone: 866-572-6436
Official record on ClinicalTrials.gov — NCT07403721
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.