Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors

Launched by REVOLUTION MEDICINES, INC. · Sep 8, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called RMC-9805 for adults with specific types of solid tumors that have a mutation known as KRAS G12D. The main goal of the study is to see how safe and well-tolerated this medication is, both when taken alone and in combination with another drug called RMC-6236. This trial is currently recruiting participants who are between the ages of 65 and 74 and have already tried other treatments for their cancer but saw their disease progress or could not tolerate those treatments.

To be eligible for this study, participants need to have a solid tumor that has been confirmed to carry the KRAS G12D mutation and should have a good performance status, meaning they are generally well enough to participate. However, those with certain conditions, like primary brain tumors or those who have had specific prior treatments, may not qualify. Participants will receive close monitoring during the trial and can expect to contribute to important research that could help improve treatments for cancers with this mutation in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Pathologically documented, locally advanced or metastatic solid tumor with a KRAS G12D-mutation
• • Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage
• • ECOG performance status 0 or 1
• • Adequate organ function
• Exclusion Criteria:
• • Primary central nervous system (CNS) tumors
• • Known or suspected leptomeningeal or active brain metastases or spinal cord compression
• • Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
• • Participant was previously treated with an investigational KRAS G12D inhibitor, pan- or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)
• • Other inclusion/exclusion criteria may apply.