D3S-001 in advanced solid tumors with KRASG12C mutations: a phase 1 trial.
Byoung Chul Cho, Shun Lu, Myung Ah Lee...
https://pubmed.ncbi.nlm.nih.gov/40301557Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID05410145
Study of D3S-001 Alone or With Other Drugs in People with Advanced Solid Tumors Having KRAS p.G12C Mutation Phase 1/2 Study Evaluating Safety, Dosing, and Early Effects of D3S-001 Oral Treatment
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
Researchers are conducting a Phase 1/2 clinical trial to study the safety, tolerability, pharmacokinetics, pharmacodynamics, and early effectiveness of D3S-001 alone or in combination with other therapies in people with advanced solid tumors that have a KRAS p.G12C mutation. This trial is a first-in-human, multicenter, open-label study focusing on tumors that are either metastatic or locally advanced and progressing despite previous treatments. Participants will receive D3S-001 orally every day in 21-day treatment cycles. The study may include combination therapies with drugs given intravenously, such as pembrolizumab, cisplatin, carboplatin, pemetrexed, and cetuximab. The trial includes dose-escalation and dose-expansion phases to evaluate different dosing levels and treatment combinations. During the study, participants will be monitored closely for adverse events and dose-limiting toxicities from the first dose until 30 days after the last dose, with each treatment cycle lasting 21 days. Researchers will assess safety, how the drug behaves in the body, and preliminary treatment effects. Participants will also undergo evaluations of their tumor response and organ function, with follow-up to ensure safety throughout the trial period.
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
Age: 18Years +
All Genders
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
1
2
3
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
Actively Recruiting
5
D3 Bio Investigative Site 0401
Detroit, Michigan, United States, 48202-2608
Actively Recruiting
6
D3 Bio Investigative Site 0405
Nashville, Tennessee, United States, 37203
Actively Recruiting
7
D3 Bio Investigative Site 0403
Houston, Texas, United States, 77030
Actively Recruiting
8
D3 Bio Investigative Site 0102
Sydney, New South Wales, Australia, 2109
Actively Recruiting
9
D3 Bio Investigative Site 0101
Malvern, Victoria, Australia, 3144
Actively Recruiting
10
D3 Bio Investigative Site 0105
Melbourne, Victoria, Australia, 3000
Actively Recruiting
11
D3 Bio Investigative Site 0103
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
12
D3 Bio Investigative Site 0104
Bedford Park, Australia, 5042
Actively Recruiting
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
Actively Recruiting
16
D3 Bio Investigative Site 0307
Harbin, Heilongjiang, China, 150081
Actively Recruiting
17
D3 Bio Investigative Site 0309
Wuhan, Hubei, China, 43000
Actively Recruiting
18
D3 Bio Investigative Site 0312
Wuhan, Hubei, China, 430079
Actively Recruiting
19
D3 Bio Investigative Site 0304
Nanchang, Jiangxi, China, 330008
Actively Recruiting
20
D3 Bio Investigative Site 0302
Shenyang, Liaoning, China, 110042
Actively Recruiting
21
D3 Bio Investigative Site 0310
Jinan, Shandong, China, 250117
Actively Recruiting
22
D3 Bio Investigative Site 0301
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
23
D3 Bio Investigative Site 0308
Shanghai, Shanghai Municipality, China, 201801
Actively Recruiting
24
D3 Bio Investigative Site 0316
Chengdu, Sichuan, China, 610041
Actively Recruiting
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
Actively Recruiting
30
D3 Bio Investigative Site 0803
Lyon, France, 69373
Actively Recruiting
31
D3 Bio Investigative Site 0801
Rennes, France, 35033
Actively Recruiting
32
D3 Bio Investigative Site 0802
Villejuif, France, 94805
Actively Recruiting
33
D3 Bio Investigative Site 1003
Cologne, North Rhine-Westphalia, Germany, 45147
Actively Recruiting
34
D3 Bio Investigative Site 1002
Hamburg, Germany, 20249
Actively Recruiting
35
D3 Bio Investigative Site 0501
Shatin, Hong Kong, 999077
Actively Recruiting
36
D3 Bio Investigative Site 0905
Candiolo, Italy, 10060
Actively Recruiting
37
D3 Bio Investigative Site 0902
Milan, Italy, 20141
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38
D3 Bio Investigative Site 0904
Naples, Italy, 80131
Actively Recruiting
39
D3 Bio Investigative Site 0901
Rome, Italy, 00144
Actively Recruiting
40
D3 Bio Investigative Site 0903
Siena, Italy, 53100
Actively Recruiting
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
Actively Recruiting
44
D3 Bio Investigative Site 0202
Seoul, South Korea, 06591
Actively Recruiting
45
D3 Bio Investigative Site 0203
Seoul, South Korea, 120-752
Actively Recruiting
46
D3 Bio Investigative Site 0201
Seoul, South Korea, 138-736
Withdrawn
47
D3 Bio Investigative Site 0706
Barcelona, Spain, 08023
Actively Recruiting
48
D3 Bio Investigative Site 0701
Barcelona, Spain, 08035
Actively Recruiting
49
D3 Bio Investigative Site 0704
Madrid, Spain, 28046
Actively Recruiting
50
D3 Bio Investigative Site 0705
Madrid, Spain, 28050
Actively Recruiting
51
D3 Bio Investigative Site 0703
Valencia, Spain, 46010
Actively Recruiting
52
D3 Bio Investigative Site 0702
Valencia, Spain, 46026
Actively Recruiting
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Research Team
M
Medical Director
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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