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Study identifier: NCT05410145 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation

Condition: KRAS P.G12C  ·  Sponsor: D3 Bio (Wuxi) Co., Ltd

PhasePhase 1/Phase 2
Planned participants442
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Medical Director  ·  +86 21 61635900  ·  D3bio_CT@d3bio.com

Always discuss trial participation with your own doctor first.

Locations (52)

D3 Bio Investigative Site 0402Orange, California, United StatesRecruiting
D3 Bio Investigative Site 0407Palo Alto, California, United StatesRecruiting
D3 Bio Investigative Site 0404Denver, Colorado, United StatesRecruiting
D3 Bio Investigative Site 0406Sarasota, Florida, United StatesRecruiting
D3 Bio Investigative Site 0401Detroit, Michigan, United StatesRecruiting
D3 Bio Investigative Site 0405Nashville, Tennessee, United StatesRecruiting
D3 Bio Investigative Site 0403Houston, Texas, United StatesRecruiting
D3 Bio Investigative Site 0102Sydney, New South Wales, AustraliaRecruiting
D3 Bio Investigative Site 0101Malvern, Victoria, AustraliaRecruiting
D3 Bio Investigative Site 0105Melbourne, Victoria, AustraliaRecruiting
D3 Bio Investigative Site 0103Nedlands, Western Australia, AustraliaRecruiting
D3 Bio Investigative Site 0104Bedford Park, AustraliaRecruiting

+ 40 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05410145