Status:
RECRUITING
A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
Lead Sponsor:
D3 Bio (Wuxi) Co., Ltd
Conditions:
KRAS P.G12C
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 prel...
Eligibility Criteria
Inclusion
- Inclusion:
- Subject must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing.
- Subject must have documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood.
- Subject must have measurable disease per RECIST v1.1.
- Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subject must have adequate organ and marrow function within the screening period.
- Exclusion:
- Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.
- Subject has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.
- Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).
- Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy.
- Concurrent participation in any clinical research study involving treatment with any investigational drug, radiotherapy, or surgery, except for the nontreatment phases of these studies (e.g., follow-up phase).
- Other protocol inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
August 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT05410145
Start Date
August 3 2022
End Date
April 1 2027
Last Update
November 14 2025
Active Locations (51)
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1
D3 Bio Investigative Site 0402
Orange, California, United States, 92868
2
D3 Bio Investigative Site 0407
Palo Alto, California, United States, 94304-2205
3
D3 Bio Investigative Site 0404
Denver, Colorado, United States, 80218-1238
4
D3 Bio Investigative Site 0406
Sarasota, Florida, United States, 34232-6410