A Phase 1/2 Study Evaluating Safety, Pharmacokinetics, and Preliminary Efficacy of D3S-001 Alone or With Other Therapies in Advanced Solid Tumors With KRAS p.G12C Mutation

What this Trial Is About

Researchers are evaluating the safety, tolerability, how the body processes, and early effectiveness of a drug called D3S-001 alone or combined with other treatments in adults with advanced solid tumors that have a specific KRAS p.G12C mutation. This first-in-human, open-label Phase 1/2 trial aims to better understand these aspects in patients with progressing metastatic or locally advanced tumors. D3 Bio (Wuxi) Co., Ltd is leading this multicenter study to explore potential treatment options for this mutation type in cancer. Participants will receive D3S-001 daily by mouth in cycles lasting 21 days. The study includes several parts: Part 1 focuses on increasing doses of D3S-001; Parts 2 and 3a Arm C involve dose expansion with D3S-001 alone for selected cancer types; Part 4a is for dose optimization. Combination therapies are also studied in Parts 3a Arms A and B, and Part 3b, where D3S-001 is given with pembrolizumab, chemotherapy drugs (cisplatin plus pemetrexed or carboplatin plus pemetrexed), or cetuximab, all administered intravenously. During the trial, participants will be closely monitored for side effects and dose-limiting toxicities from the first dose through the treatment cycles. Researchers will collect blood samples to measure drug levels and track tumor response using standard criteria up to 24 months. Additional assessments include performance status, organ function tests, and imaging to measure tumor size. The study will continue until 30 days after the last dose, with ongoing evaluation of safety, drug behavior in the body, and preliminary treatment effects.

A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation