Actively Recruiting
A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
Led by D3 Bio (Wuxi) Co., Ltd · Updated on 2026-03-12
442
Participants Needed
52
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic or locally advanced solid tumor that is progressing
- Documented KRAS p.G12C mutation identified within the last 5 years by local testing on tumor tissue or blood
- Measurable disease according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and marrow function within the screening period
You will not qualify if you...
- Prior treatments without adequate washout periods as defined in the protocol
- Uncontrolled illnesses such as active infection, significant cardiovascular disease, serious chronic gastrointestinal conditions with diarrhea, or psychiatric/social conditions limiting study compliance or consent
- Unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade 2 or higher (except vitiligo or alopecia)
- Active gastrointestinal disease or other conditions interfering with oral therapy absorption or metabolism
- Participation in other clinical research treatment studies, except non-treatment follow-up phases
- Other protocol inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 52 locations
1
D3 Bio Investigative Site 0402
Orange, California, United States, 92868
Actively Recruiting
2
D3 Bio Investigative Site 0407
Palo Alto, California, United States, 94304-2205
Actively Recruiting
3
D3 Bio Investigative Site 0404
Denver, Colorado, United States, 80218-1238
Actively Recruiting
4
D3 Bio Investigative Site 0406
Sarasota, Florida, United States, 34232-6410
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5
D3 Bio Investigative Site 0401
Detroit, Michigan, United States, 48202-2608
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6
D3 Bio Investigative Site 0405
Nashville, Tennessee, United States, 37203
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7
D3 Bio Investigative Site 0403
Houston, Texas, United States, 77030
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8
D3 Bio Investigative Site 0102
Sydney, New South Wales, Australia, 2109
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9
D3 Bio Investigative Site 0101
Malvern, Victoria, Australia, 3144
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10
D3 Bio Investigative Site 0105
Melbourne, Victoria, Australia, 3000
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11
D3 Bio Investigative Site 0103
Nedlands, Western Australia, Australia, 6009
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12
D3 Bio Investigative Site 0104
Bedford Park, Australia, 5042
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13
D3 Bio Investigative Site 0303
Beijing, Beijing Municipality, China, 100036
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14
D3 Bio Investigative Site 0306
Guangzhou, Guangdong, China, 510120
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15
D3 Bio Investigative Site 0305
Hangzhou, Hangzhou, China, 310022
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16
D3 Bio Investigative Site 0307
Harbin, Heilongjiang, China, 150081
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17
D3 Bio Investigative Site 0309
Wuhan, Hubei, China, 43000
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18
D3 Bio Investigative Site 0312
Wuhan, Hubei, China, 430079
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19
D3 Bio Investigative Site 0304
Nanchang, Jiangxi, China, 330008
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20
D3 Bio Investigative Site 0302
Shenyang, Liaoning, China, 110042
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21
D3 Bio Investigative Site 0310
Jinan, Shandong, China, 250117
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22
D3 Bio Investigative Site 0301
Shanghai, Shanghai Municipality, China, 200030
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23
D3 Bio Investigative Site 0308
Shanghai, Shanghai Municipality, China, 201801
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24
D3 Bio Investigative Site 0316
Chengdu, Sichuan, China, 610041
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25
D3 Bio Investigative Site 0311
Hangzhou, Zhejiang, China, 310003
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26
D3 Bio Investigative Site 0315
Changsha, China, 410013
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27
D3 Bio Investigative Site 0314
Hefei, China, 230000
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28
D3 Bio Investigative Site 0313
Zhengzhou, China, 450003
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29
D3 Bio Investigative Site 0804
Bordeaux, France, 33000
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30
D3 Bio Investigative Site 0803
Lyon, France, 69373
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31
D3 Bio Investigative Site 0801
Rennes, France, 35033
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32
D3 Bio Investigative Site 0802
Villejuif, France, 94805
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33
D3 Bio Investigative Site 1003
Cologne, North Rhine-Westphalia, Germany, 45147
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34
D3 Bio Investigative Site 1002
Hamburg, Germany, 20249
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35
D3 Bio Investigative Site 0501
Shatin, Hong Kong, 999077
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36
D3 Bio Investigative Site 0905
Candiolo, Italy, 10060
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37
D3 Bio Investigative Site 0902
Milan, Italy, 20141
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38
D3 Bio Investigative Site 0904
Naples, Italy, 80131
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39
D3 Bio Investigative Site 0901
Rome, Italy, 00144
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40
D3 Bio Investigative Site 0903
Siena, Italy, 53100
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41
D3 Bio Investigative Site 0601
Kashiwa, Japan, 277-8577
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42
D3 Bio Investigative Site 0602
Tokyo, Japan, 104-0045
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43
D3 Bio Investigative Site 0204
Cheongju-si, North Chungcheong, South Korea, 28644
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44
D3 Bio Investigative Site 0202
Seoul, South Korea, 06591
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45
D3 Bio Investigative Site 0203
Seoul, South Korea, 120-752
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46
D3 Bio Investigative Site 0201
Seoul, South Korea, 138-736
Withdrawn
47
D3 Bio Investigative Site 0706
Barcelona, Spain, 08023
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48
D3 Bio Investigative Site 0701
Barcelona, Spain, 08035
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49
D3 Bio Investigative Site 0704
Madrid, Spain, 28046
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50
D3 Bio Investigative Site 0705
Madrid, Spain, 28050
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51
D3 Bio Investigative Site 0703
Valencia, Spain, 46010
Actively Recruiting
52
D3 Bio Investigative Site 0702
Valencia, Spain, 46026
Actively Recruiting
Research Team
M
Medical Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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