Actively Recruiting
A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation.
Led by D3 Bio (Wuxi) Co., Ltd · Updated on 2026-04-13
42
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have histologically confirmed locally advanced, recurrent, or metastatic cancer that progressed after at least one standard treatment or for which standard options are ineffective, intolerable, or inappropriate
- Must have documented KRAS p.G12D mutation from tumor tissue or blood collected within the last 5 years
- Must have measurable disease according to RECIST v1.1 criteria
- Must have an ECOG performance status of 0 or 1
- Must have adequate organ and marrow function at screening
You will not qualify if you...
- Prior treatment with a KRAS G12D inhibitor/degrader or pan RAS inhibitor/degrader
- Uncontrolled intercurrent illness such as serious chronic gastrointestinal conditions with diarrhea, active infections, uncontrolled significant cardiovascular disease, autoimmune or inflammatory disorders, or psychiatric/social situations limiting study compliance or consent
- Uncontrolled or untreated brain metastases
- Active gastrointestinal disease or other conditions affecting absorption, distribution, metabolism, or excretion of oral therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
D3 Bio Investigative Site 1402
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
M
Medical Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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