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A Phase 1/2, Open Label, Dose-escalation, and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
D3 Bio Investigative Site 0402
Orange, California, United States
D3 Bio Investigative Site 0407
Palo Alto, California, United States
D3 Bio Investigative Site 0404
Denver, Colorado, United States
D3 Bio Investigative Site 0406
Sarasota, Florida, United States
D3 Bio Investigative Site 0401
Detroit, Michigan, United States
D3 Bio Investigative Site 0405
Nashville, Tennessee, United States
D3 Bio Investigative Site 0403
Houston, Texas, United States
D3 Bio Investigative Site 0102
Sydney, New South Wales, Australia
D3 Bio Investigative Site 0101
Malvern, Victoria, Australia
D3 Bio Investigative Site 0105
Melbourne, Victoria, Australia
Start Date
August 3, 2022
Primary Completion Date
April 1, 2027
Completion Date
April 1, 2027
Last Updated
March 12, 2026
442
ESTIMATED participants
D3S-001
DRUG
Pembrolizumab
DRUG
Cisplatin
DRUG
Carboplatin
DRUG
Pemetrexed
DRUG
Cetuximab
DRUG
Lead Sponsor
D3 Bio (Wuxi) Co., Ltd
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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