This is an open-label, multicenter, Phase 1/1b study of RMC-9805, monotherapy, selective and orally bioavailable KRAS G12D(ON) inhibitor, in subjects with KRASG12D-mutant solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of two parts: Part 1- Dose-Exploration and Part 2- Dose-Expansion.
Pathologically documented, locally advanced or metastatic solid tumor malignancy with KRASG12D-mutations identified through deoxyribonucleic acid (DNA) sequencing or polymerase chain reaction (PCR) test 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 KRASG12D inhibitor or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)
