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A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation.
Sponsor: D3 Bio (Wuxi) Co., Ltd
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.
Official title: A Phase 1, Open-label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-003 Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2026-05-29
Completion Date
2028-01-11
Last Updated
2026-06-04
Healthy Volunteers
No
Conditions
Interventions
D3S-003
Oral Tablet
Locations (5)
D3 Bio Investigative Site 1402
San Antonio, Texas, United States
D3 Bio Investigative Site 1103
Randwick, New South Wales, Australia
D3 Bio Investigative Site 1201
Seoul, South Korea
D3 Bio Investigative Site 1203
Seoul, South Korea
D3 Bio Investigative Site 1202
Seoul, South Korea