A Phase I/II Study of AMG 410 Monotherapy and Combination Therapy in Participants with KRAS-Altered Advanced or Metastatic Solid Tumors

The primary objective of this study is to evaluate the efficacy of AMG 410, administered as a monotherapy or in combination with other agents, in patients diagnosed with KRAS-altered advanced or metastatic solid tumors. Determining the therapeutic response in this specific molecular subgroup is clinically significant due to the targeting of oncogenic drivers. There are no secondary objectives reported.

The study involves a total of 294 patients. The study population consists of both male and female individuals. Participants are identified as a vulnerable population. The subjects are diagnosed with KRAS-altered advanced or metastatic solid tumors. Age classifications for the participants include the 3 and 4 age ranges.

This Phase 1 clinical trial is designed to evaluate the efficacy and safety of AMG 410 administered as a monotherapy or in combination with other agents in participants diagnosed with KRAS-altered advanced or metastatic solid tumors. The study protocol involves a screening visit to assess eligibility based on predefined inclusion and exclusion criteria. Following successful screening, participants proceed through scheduled follow-up visits to monitor clinical responses and safety profiles, concluding with an end-of-study visit. The total duration of the study is estimated to span from October 2025 to October 2030. Participant involvement is subject to clinical conditions that may necessitate early termination from the study to ensure safety.

The assessment of efficacy in this phase 1 clinical trial for KRAS-altered advanced or metastatic solid tumors is not specified.