Phase 11b Study of AMG 436 to Evaluate Safety and Dosage Alone and with Other Treatments in Adults with MSI-H or dMMR Solid Tumors

What this Trial Is About

Researchers are evaluating AMG 436, a drug being studied for safety and optimal dosing, in participants with metastatic or locally advanced solid tumors that have microsatellite instability-high MSI-H or mismatch repair deficiency dMMR. This Phase 11b trial aims to determine the maximum tolerated dose and recommended dose of AMG 436 both as a single therapy and combined with other anti-cancer treatments. The study focuses on safety, tolerability, and how the drug behaves in the body. Participants may receive AMG 436 alone or in combination with other therapies. The study includes several parts dose escalation for monotherapy, evaluation under fed and fasted conditions in the US, combination dose escalation, dose expansion and optimization of monotherapy, and combination dose expansions with chemotherapy. Each part explores different dosing strategies and combinations to find the best approach. During the study, participants will be monitored closely for side effects and dose-limiting toxicities up to 21 days after dosing, with continued safety follow-up for up to five years. Blood samples will be collected to measure drug levels and activity. Tumor response will be assessed using standard imaging criteria over several years to evaluate treatment effectiveness. Participants will have regular visits for assessments, and overall survival and disease progression will be tracked for up to five years.

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