Phase 1/1b, Multicenter, Open-LabeL, Study of RMC-9805 in Participants with Advanced KRASG12D-Mutant Solid Tumors
Phase 1/1b, Multicenter, Open-LabeL, Study of RMC-9805 in Participants with Advanced KRASG12D-Mutant Solid Tumors
Mechanism of Action
RMC-9805 is a KRAS G12D inhibitor
Purpose
The purpose of this study is to test a new drug called RMC-9805 (the study drug).
- 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
- 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)
Pathologically documented, locally advanced or metastatic solid tumor malignancy with KRASG12D-mutations identified through deoxyribonucleic acid (DNA) sequencing or polymerase chain reaction (PCR) test of an archival biopsy or circulating tumor DNA (ctDNA) obtained within 5 years of C1D1 from a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory or equivalent laboratory.
Participants with no more than 3 prior lines of systemic therapy may be enrolled into Part 2 (Dose Expansion). A participant with more than 3 prior lines of systemic therapy may be enrolled into Part 2 (Dose Expansion) upon the approval of the Medical Monitor after discussion with the Investigator.
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