This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.
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
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)
Parallel
RMC-9805
DrugOral Tablets
RMC-6236
DrugOral Tablets
Adverse events
Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs, and vital signs
Dose Limiting Toxicities
Number of participants with Dose Limiting Toxicities (DLTs)
Maximum Observed Blood Concentration (Cmax) of RMC-9805 as monotherapy and in combination with RMC-6236, and Cmax of RMC-6236 in combination with RMC-9805
Cmax
Time to Reach Maximum Blood Concentration (Tmax) of RMC-9805 as monotherapy and in combination with RMC-6236, and Tmax of RMC-6236 in combination with RMC-9805
Tmax
Area Under Blood Concentration Time Curve (AUC) of RMC-9805 as monotherapy and in combination with RMC-6236, and AUC of RMC-6236 in combination with RMC-9805
AUC
Ratio of accumulation of RMC-9805 from a single dose to steady state with repeated dosing as monotherapy and in combination with RMC-6236, and ratio of accumulation of RMC-6236 in combination with RMC-9805
accumulation ratio
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