This phase I study is seeking to understand the appropriate dose level, safety and effectiveness of a new targeted therapy (D3S-001) in people with advanced solid cancers with the Kirsten rat sarcoma viral oncogene homolog gene (KRAS) p.G12C mutationA Phase 1, Open-label, Dose-escalation and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-001 Monotherapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation

Exclusion

• Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.
• Subject has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.
• Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).
• Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy.
• Concurrent participation in any clinical research study involving treatment with any investigational drug, radiotherapy, or surgery, except for the nontreatment phases of these studies (e.g., follow-up phase).