Clinical Trial

A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation.

Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
This is a first-in-human (FIH) multicenter, open-label, dose-escalation Phase 1 clinical trial to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of D3S-003 in participants with advanced KRAS p.G12D mutant solid tumors.
Protocol Amendment History 3 changes
notable Trial sites expanded: 5 -> 8 locations 2026-08-04
notable Trial sites expanded: 1 -> 5 locations 2026-06-05
critical Recruitment opened 2026-04-14
Trial Details
NCT Number NCT07456046
Lead Sponsor D3 Bio (Wuxi) Co., Ltd
Conditions KRAS P.G12D
Enrollment 42 participants
Start Date 2026-05-29
Primary Completion 2028-01-11 (estimated)
Study Completion 2028-01-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-03