A Phase II Study of AMG 436 Monotherapy and Combination Therapy in Participants with Microsatellite Instability-High/Mismatch Repair Deficient (MSI-H/dMMR) Solid Tumors

The primary objective of this study is to evaluate the efficacy of AMG 436 as a monotherapy and in combination therapy for individuals diagnosed with microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) solid tumors. This investigation aims to determine the therapeutic potential of the agent in this specific molecular subgroup to address clinical needs in oncology. 5

The study involves a total of 387 patients diagnosed with microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) solid tumors. The study population includes both males and females. The age range corresponds to specific cohorts identified by codes 3 and 4. The sponsor did not provide information regarding lifestyle considerations or specific selection processes.

This Phase 1 clinical trial evaluates the efficacy and safety of AMG 436 administered as both monotherapy and combination therapy in participants diagnosed with microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) solid tumors. The study design involves a sequence of scheduled clinical assessments beginning with a screening visit to determine eligibility. Subsequent follow-up visits are conducted to monitor clinical responses and safety profiles, concluding with an end-of-study visit. The total duration of study activities is estimated to extend from May 2026 through April 2032. Participation may be subject to early termination based on predefined clinical criteria.

The assessment of efficacy in this Phase 1 clinical trial involving patients with microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) solid tumors will be conducted according to the study protocol. Specific parameters for evaluating therapeutic response are not detailed in the provided documentation.