Brief Summary
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 advancedat a late stage, far along KRAS p.G12C mutant solid tumors. D3S-001 will be taken daily by oral administration in 21-day treatment cycles.
Intervention / Treatment
- Drug: D3S-001
- Drug: Pembrolizumab
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Pemetrexed
- Drug: Cetuximab
Inclusion Criteria:
- 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 tissuea group of cells that work together to perform a function or bloodthe red bodily fluid that transports oxygen and other nutrients around the body.
- Subject must have measurable disease per RECIST v1.1.
- Subject must have Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 or 1.
- Subject must have adequate organ and marrow function within the screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening period.