Clinical Trial

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

Recruiting Phase 1/2
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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 advanced KRAS p.G12C mutant solid tumors. D3S-001 will be taken daily by oral administration in 21-day treatment cycles.
Protocol Amendment History 37 amendments
This ClinicalTrials.gov record has been amended 37 times since 2022-06-06; most recent amendment 2026-03-10.
Status change: Not Yet Recruiting → Recruiting 2022-07-13
Trial Details
NCT Number NCT05410145
Lead Sponsor D3 Bio (Wuxi) Co., Ltd
Conditions KRAS P.G12C
Enrollment 442 participants
Start Date 2022-08-03
Primary Completion 2027-04 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-03-12