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A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
Sponsor: D3 Bio (Wuxi) Co., Ltd
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 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
442
Start Date
2022-08-03
Completion Date
2027-04
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
D3S-001
Oral
Pembrolizumab
Intravenous
Cisplatin
Intravenous
Carboplatin
Intravenous
Pemetrexed
Intravenous
Cetuximab
Intravenous
Locations (52)
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
D3 Bio Investigative Site 0103
Nedlands, Western Australia, Australia
D3 Bio Investigative Site 0104
Bedford Park, Australia
D3 Bio Investigative Site 0303
Beijing, Beijing Municipality, China
D3 Bio Investigative Site 0306
Guangzhou, Guangdong, China
D3 Bio Investigative Site 0305
Hangzhou, Hangzhou, China
D3 Bio Investigative Site 0307
Harbin, Heilongjiang, China
D3 Bio Investigative Site 0309
Wuhan, Hubei, China
D3 Bio Investigative Site 0312
Wuhan, Hubei, China
D3 Bio Investigative Site 0304
Nanchang, Jiangxi, China
D3 Bio Investigative Site 0302
Shenyang, Liaoning, China
D3 Bio Investigative Site 0310
Jinan, Shandong, China
D3 Bio Investigative Site 0301
Shanghai, Shanghai Municipality, China
D3 Bio Investigative Site 0308
Shanghai, Shanghai Municipality, China
D3 Bio Investigative Site 0316
Chengdu, Sichuan, China
D3 Bio Investigative Site 0311
Hangzhou, Zhejiang, China
D3 Bio Investigative Site 0315
Changsha, China
D3 Bio Investigative Site 0314
Hefei, China
D3 Bio Investigative Site 0313
Zhengzhou, China
D3 Bio Investigative Site 0804
Bordeaux, France
D3 Bio Investigative Site 0803
Lyon, France
D3 Bio Investigative Site 0801
Rennes, France
D3 Bio Investigative Site 0802
Villejuif, France
D3 Bio Investigative Site 1003
Cologne, North Rhine-Westphalia, Germany
D3 Bio Investigative Site 1002
Hamburg, Germany
D3 Bio Investigative Site 0501
Shatin, Hong Kong
D3 Bio Investigative Site 0905
Candiolo, Italy
D3 Bio Investigative Site 0902
Milan, Italy
D3 Bio Investigative Site 0904
Naples, Italy
D3 Bio Investigative Site 0901
Rome, Italy
D3 Bio Investigative Site 0903
Siena, Italy
D3 Bio Investigative Site 0601
Kashiwa, Japan
D3 Bio Investigative Site 0602
Tokyo, Japan
D3 Bio Investigative Site 0204
Cheongju-si, North Chungcheong, South Korea
D3 Bio Investigative Site 0202
Seoul, South Korea
D3 Bio Investigative Site 0203
Seoul, South Korea
D3 Bio Investigative Site 0201
Seoul, South Korea
D3 Bio Investigative Site 0706
Barcelona, Spain
D3 Bio Investigative Site 0701
Barcelona, Spain
D3 Bio Investigative Site 0704
Madrid, Spain
D3 Bio Investigative Site 0705
Madrid, Spain
D3 Bio Investigative Site 0703
Valencia, Spain
D3 Bio Investigative Site 0702
Valencia, Spain