This is a first-in-human (FIH), multicenter, open-label, dose-escalation, and dose-expansion Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of D3S-001 or combination therapy in subjects with advanced KRAS p.G12C mutant solid tumors. D3S-001 will be taken daily by oral administration in 21-day treatment cycles.
Subject must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing.
Subject must have documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood.
Subject must have measurable disease per RECIST v1.1.
Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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