A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
Recruiting now · Phase 1/Phase 2
Conditions studied: KRAS P.G12C
In brief
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.
Key facts
- Study ID
- NCT05410145
- Run by
- D3 Bio (Wuxi) Co., Ltd
- People needed
- 442
- Starts
- 2022-08-03
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-03-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- D3 Bio Investigative Site 0407 — Palo Alto, California, United States (enrolling)
- D3 Bio Investigative Site 0404 — Denver, Colorado, United States (enrolling)
- D3 Bio Investigative Site 0406 — Sarasota, Florida, United States (enrolling)
- D3 Bio Investigative Site 0401 — Detroit, Michigan, United States (enrolling)
- D3 Bio Investigative Site 0405 — Nashville, Tennessee, United States (enrolling)
- D3 Bio Investigative Site 0403 — Houston, Texas, United States (enrolling)
- D3 Bio Investigative Site 0102 — Sydney, New South Wales, Australia (enrolling)
- D3 Bio Investigative Site 0101 — Malvern, Victoria, Australia (enrolling)
- D3 Bio Investigative Site 0105 — Melbourne, Victoria, Australia (enrolling)
- D3 Bio Investigative Site 0103 — Nedlands, Western Australia, Australia (enrolling)
- D3 Bio Investigative Site 0104 — Bedford Park, Australia (enrolling)
- D3 Bio Investigative Site 0303 — Beijing, Beijing Municipality, China (enrolling)
- D3 Bio Investigative Site 0306 — Guangzhou, Guangdong, China (enrolling)
- D3 Bio Investigative Site 0305 — Hangzhou, Hangzhou, China (enrolling)
- D3 Bio Investigative Site 0307 — Harbin, Heilongjiang, China (enrolling)
- D3 Bio Investigative Site 0309 — Wuhan, Hubei, China (enrolling)
- D3 Bio Investigative Site 0312 — Wuhan, Hubei, China (enrolling)
- D3 Bio Investigative Site 0304 — Nanchang, Jiangxi, China (enrolling)
- D3 Bio Investigative Site 0302 — Shenyang, Liaoning, China (enrolling)
- D3 Bio Investigative Site 0310 — Jinan, Shandong, China (enrolling)
- D3 Bio Investigative Site 0301 — Shanghai, Shanghai Municipality, China (enrolling)
- D3 Bio Investigative Site 0308 — Shanghai, Shanghai Municipality, China (enrolling)
- D3 Bio Investigative Site 0316 — Chengdu, Sichuan, China (enrolling)
- D3 Bio Investigative Site 0311 — Hangzhou, Zhejiang, China (enrolling)
- D3 Bio Investigative Site 0402 — Orange, California, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.