A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
Start Date
8/3/2022
Completion Date
4/1/2027
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
D3S-001
Pembrolizumab
Cisplatin
Carboplatin
Pemetrexed
Cetuximab
Conditions
Locations
D3 Bio Investigative Site 0402
Orange, California 92868
United States
D3 Bio Investigative Site 0407
Palo Alto, California 94304-2205
United States
D3 Bio Investigative Site 0404
Denver, Colorado 80218-1238
United States
D3 Bio Investigative Site 0406
Sarasota, Florida 34232-6410
United States
D3 Bio Investigative Site 0401
Detroit, Michigan 48202-2608
United States
D3 Bio Investigative Site 0405
Nashville, Tennessee 37203
United States
D3 Bio Investigative Site 0403
Houston, Texas 77030
United States
D3 Bio Investigative Site 0102
Sydney, New South Wales 2109
Australia
D3 Bio Investigative Site 0101
Malvern, Victoria 3144
Australia
D3 Bio Investigative Site 0105
Melbourne, Victoria 3000
Australia
D3 Bio Investigative Site 0103
Nedlands, Western Australia 6009
Australia
D3 Bio Investigative Site 0104
Bedford Park, 5042
Australia
D3 Bio Investigative Site 0303
Beijing, Beijing Municipality 100036
China
D3 Bio Investigative Site 0306
Guangzhou, Guangdong 510120
China
D3 Bio Investigative Site 0305
Hangzhou, Hangzhou 310022
China
D3 Bio Investigative Site 0307
Harbin, Heilongjiang 150081
China
D3 Bio Investigative Site 0309
Wuhan, Hubei 43000
China
D3 Bio Investigative Site 0312
Wuhan, Hubei 430079
China
D3 Bio Investigative Site 0304
Nanchang, Jiangxi 330008
China
D3 Bio Investigative Site 0302
Shenyang, Liaoning 110042
China
D3 Bio Investigative Site 0310
Jinan, Shandong 250117
China
D3 Bio Investigative Site 0301
Shanghai, Shanghai Municipality 200030
China
D3 Bio Investigative Site 0308
Shanghai, Shanghai Municipality 201801
China
D3 Bio Investigative Site 0316
Chengdu, Sichuan 610041
China
D3 Bio Investigative Site 0311
Hangzhou, Zhejiang 310003
China
D3 Bio Investigative Site 0315
Changsha, 410013
China
D3 Bio Investigative Site 0314
Hefei, 230000
China
D3 Bio Investigative Site 0313
Zhengzhou, 450003
China
D3 Bio Investigative Site 0804
Bordeaux, 33000
France
D3 Bio Investigative Site 0803
Lyon, 69373
France
D3 Bio Investigative Site 0801
Rennes, 35033
France
D3 Bio Investigative Site 0802
Villejuif, 94805
France
D3 Bio Investigative Site 1003
Cologne, North Rhine-Westphalia 45147
Germany
D3 Bio Investigative Site 1002
Hamburg, 20249
Germany
D3 Bio Investigative Site 0501
Shatin, 999077
Hong Kong
D3 Bio Investigative Site 0905
Candiolo, 10060
Italy
D3 Bio Investigative Site 0902
Milan, 20141
Italy
D3 Bio Investigative Site 0904
Naples, 80131
Italy
D3 Bio Investigative Site 0901
Rome, 00144
Italy
D3 Bio Investigative Site 0903
Siena, 53100
Italy
D3 Bio Investigative Site 0601
Kashiwa, 277-8577
Japan
D3 Bio Investigative Site 0602
Tokyo, 104-0045
Japan
D3 Bio Investigative Site 0204
Cheongju-si, North Chungcheong 28644
South Korea
D3 Bio Investigative Site 0202
Seoul, 06591
South Korea
D3 Bio Investigative Site 0203
Seoul, 120-752
South Korea
D3 Bio Investigative Site 0201
Seoul, 138-736
South Korea
D3 Bio Investigative Site 0706
Barcelona, 08023
Spain
D3 Bio Investigative Site 0701
Barcelona, 08035
Spain
D3 Bio Investigative Site 0704
Madrid, 28046
Spain
D3 Bio Investigative Site 0705
Madrid, 28050
Spain
D3 Bio Investigative Site 0703
Valencia, 46010
Spain
D3 Bio Investigative Site 0702
Valencia, 46026
Spain