Colon Cancer Clinical Trial
Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors
This study is to evaluate the safety and tolerability of RMC-9805 in adults with KRAS G12D-mutant solid tumors.
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
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)
Other inclusion/exclusion criteria may apply.
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There are 2 Locations for this study
San Antonio Texas, 78229, United States
Fairfax Virginia, 22031, United States
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