AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors (NCT07403721) | Clinical Trial Compass
RecruitingPhase 1
AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors
United States, Australia, China464 participantsStarted 2026-04-08
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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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) …
What they're measuring
1
Number of Participants with a Dose Limiting Toxicity (DLT)
Timeframe: Up to 21 days
2
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)