KRAS P.G12CPhase 1/2NCT05410145
A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
A Phase 1/2 study testing D3S-001, Pembrolizumab and Cisplatin in people with KRAS P.G12C, run by D3 Bio (Wuxi) Co., Ltd at 52 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- KRAS P.G12C
- What is being tested?
- D3S-001, Pembrolizumab and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 52 sitesin 10 countries
- Study dates
- 3 Aug 2022to Apr 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing.
- Subject must have documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood.
- Subject must have measurable disease per RECIST v1.1.
- Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subject must have adequate organ and marrow function within the screening period.
Who cannot join
- Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.
- Subject has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.
- Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).
- Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy.
- Concurrent participation in any clinical research study involving treatment with any investigational drug, radiotherapy, or surgery, except for the nontreatment phases of these studies (e.g., follow-up phase).
- Other protocol inclusion/exclusion criteria may apply
Trial locations and contacts
52 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
52 sites in 10 countries
China16 sites, 16 recruiting
- Recruiting
D3 Bio Investigative Site 0303
Beijing, Beijing Municipality, 100036
- Recruiting
D3 Bio Investigative Site 0315
Changsha, Hunan, 410013
- Recruiting
D3 Bio Investigative Site 0316
Chengdu, Sichuan, 610041
- Recruiting
D3 Bio Investigative Site 0306
Guangzhou, Guangdong, 510120
- Recruiting
D3 Bio Investigative Site 0305
Hangzhou, Hangzhou, 310022
- Recruiting
D3 Bio Investigative Site 0311
Hangzhou, Zhejiang, 310003
- Recruiting
D3 Bio Investigative Site 0307
Harbin, Heilongjiang, 150081
- Recruiting
D3 Bio Investigative Site 0314
Hefei, Anhui, 230000
- Recruiting
D3 Bio Investigative Site 0310
Jinan, Shandong, 250117
- Recruiting
D3 Bio Investigative Site 0304
Nanchang, Jiangxi, 330008
- Recruiting
D3 Bio Investigative Site 0301
Shanghai, Shanghai Municipality, 200030
- Recruiting
D3 Bio Investigative Site 0308
Shanghai, Shanghai Municipality, 201801
- Recruiting
D3 Bio Investigative Site 0302
Shenyang, Liaoning, 110042
- Recruiting
D3 Bio Investigative Site 0309
Wuhan, Hubei, 43000
- Recruiting
D3 Bio Investigative Site 0312
Wuhan, Hubei, 430079
- Recruiting
D3 Bio Investigative Site 0313
Zhengzhou, Hunan, 450003
United States7 sites, 7 recruiting
- Recruiting
D3 Bio Investigative Site 0404
Denver, Colorado, 80218-1238
- Recruiting
D3 Bio Investigative Site 0401
Detroit, Michigan, 48202-2608
- Recruiting
D3 Bio Investigative Site 0403
Houston, Texas, 77030
- Recruiting
D3 Bio Investigative Site 0405
Nashville, Tennessee, 37203
- Recruiting
D3 Bio Investigative Site 0402
Orange, California, 92868
- Recruiting
D3 Bio Investigative Site 0407
Palo Alto, California, 94304-2205
- Recruiting
D3 Bio Investigative Site 0406
Sarasota, Florida, 34232-6410
Spain6 sites, 6 recruiting
- Recruiting
D3 Bio Investigative Site 0706
Barcelona, 08023
- Recruiting
D3 Bio Investigative Site 0701
Barcelona, 08035
- Recruiting
D3 Bio Investigative Site 0704
Madrid, 28046
- Recruiting
D3 Bio Investigative Site 0705
Madrid, 28050
- Recruiting
D3 Bio Investigative Site 0703
Valencia, 46010
- Recruiting
D3 Bio Investigative Site 0702
Valencia, 46026
Australia5 sites, 5 recruiting
- Recruiting
D3 Bio Investigative Site 0104
Bedford Park, 5042
- Recruiting
D3 Bio Investigative Site 0101
Malvern, Victoria, 3144
- Recruiting
D3 Bio Investigative Site 0105
Melbourne, Victoria, 3000
- Recruiting
D3 Bio Investigative Site 0103
Nedlands, Western Australia, 6009
- Recruiting
D3 Bio Investigative Site 0102
Sydney, New South Wales, 2109
Italy5 sites, 5 recruiting
- Recruiting
D3 Bio Investigative Site 0905
Candiolo, 10060
- Recruiting
D3 Bio Investigative Site 0902
Milan, 20141
- Recruiting
D3 Bio Investigative Site 0904
Naples, 80131
- Recruiting
D3 Bio Investigative Site 0901
Rome, 00144
- Recruiting
D3 Bio Investigative Site 0903
Siena, 53100
France4 sites, 4 recruiting
- Recruiting
D3 Bio Investigative Site 0804
Bordeaux, 33000
- Recruiting
D3 Bio Investigative Site 0803
Lyon, 69373
- Recruiting
D3 Bio Investigative Site 0801
Rennes, 35033
- Recruiting
D3 Bio Investigative Site 0802
Villejuif, 94805
South Korea4 sites, 3 recruiting
- Recruiting
D3 Bio Investigative Site 0204
Cheongju-si, North Chungcheong, 28644
- Recruiting
D3 Bio Investigative Site 0202
Seoul, 06591
- Recruiting
D3 Bio Investigative Site 0203
Seoul, 120-752
- Withdrawn
D3 Bio Investigative Site 0201
Seoul, 138-736
Germany2 sites, 2 recruiting
- Recruiting
D3 Bio Investigative Site 1003
Cologne, North Rhine-Westphalia, 45147
- Recruiting
D3 Bio Investigative Site 1002
Hamburg, 22297
Japan2 sites, 2 recruiting
- Recruiting
D3 Bio Investigative Site 0601
Kashiwa, 277-8577
- Recruiting
D3 Bio Investigative Site 0602
Tokyo, 104-0045
Hong Kong1 site, 1 recruiting
- Recruiting
D3 Bio Investigative Site 0501
Shatin, 999077
About this study
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
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
- KRAS P.G12C
- Being tested
- D3S-001, Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed
- Keywords
- KRAS p.G12C, Mutation, advanced solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D3S-001Drug
Oral
PembrolizumabDrug
Intravenous
CisplatinDrug
Intravenous
CarboplatinDrug
Intravenous
PemetrexedDrug
Intravenous
CetuximabDrug
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| D3S-001 monotherapy | Experimental | Part 1: Dose Escalation, D3S-001 administered orally.
Part 2 and Part 3a Arm C: Dose Expansion, D3S-001 administered orally in selected cancer type patients.
Part 4a: Dose Optimization, D3S-001 administered orally in selected cancer type patients. Receives: Drug: D3S-001 |
| D3S-001 and pembrolizumab | Experimental | Part 3a Arm A: Dose Expansion, D3S-001 in combination therapy administered orally in selected cancer type patients.
Pembrolizumab administered intravenously. Receives: Drug: D3S-001; Drug: Pembrolizumab |
| D3S-001 and platinum doublet chemotherapy (cisplatin + pemetrexed or carboplatin + pemetrexed) | Experimental | Part 3a Arm B: Dose Expansion, D3S-001 in combination therapy administered orally in selected cancer type patients.
Cisplatin + pemetrexed administered intravenously
or
Carboplatin + pemetrexed administered intravenously Receives: Drug: D3S-001; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed |
| D3S-001 and Cetuximab | Experimental | Part 3b: Dose Expansion, D3S-001 in combination therapy administered orally in selected cancer type patients.
Cetuximab administered intravenously. Receives: Drug: D3S-001; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
Measured: From first dose until 30 days after the last dose (or specified in the protocol).
Number of Participants With Dose-Limiting Toxicities (DLTs)
Measured: From Cycle 1 Day 1 through Day 21. Each cycle is 21 days.
Secondary outcomes (8)
D3S-001 maximum observed plasma concentration (Cmax)
Measured: Up to 24 months.
D3S-001 time to maximum plasma concentration (tmax)
Measured: Up to 24 months.
D3S-001 half-life (t1/2)
Measured: Up to 24 months.
D3S-001 area under the concentration-time curve (AUC)
Measured: Up to 24 months.
Objective response rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Measured: Up to 24 months.
Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Measured: Up to 24 months.
Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Measured: Up to 24 months.
Disease Control Rate (DCR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Measured: Up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start3 Aug 2022
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KRAS P.G12CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 442 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D3 Bio (Wuxi) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cheng Chen, MD, Study director, D3 Bio (Wuxi) Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410145
- Sponsor's protocol ID
- D3S-001-100
- Other IDs
- 2023-508517-16, 2023
- Status last verified
- Sep 2026
- First submitted
- 25 May 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho BC, Lu S, Lee MA, Song Z, Park JJ, Lim SM, Li Z, Zhao J, Richardson G, Zhang Y, Zhang J, Liu A, Loong HH, Chen C, Wang J, Shen Y, Fan Z, Chen Q, Wang H, Zhang J, Chen ZJ, Johnson ML, Mok T. D3S-001 in advanced solid tumors with KRASG12C mutations: a phase 1 trial. Nat Med. 2025 Aug;31(8):2768-2777. doi: 10.1038/s41591-025-03688-6. Epub 2025 Apr 29.
PubMed 40301557
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05410145
- Acronym / sponsor ID
- D3S-001-100
- Conditions
- KRAS P.G12C
- Keywords
- KRAS p.G12C, Mutation, advanced solid tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 442 participants (estimated)
- Lead sponsor
- D3 Bio (Wuxi) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| D3S-001 monotherapy | Experimental | Drug: D3S-001Part 1: Dose Escalation, D3S-001 administered orally. Part 2 and Part 3a Arm C: Dose Expansion, D3S-001 administered orally in selected cancer type patients. Part 4a: Dose Optimization, D3S-001 administered orally in selected cancer type patients. |
| D3S-001 and pembrolizumab | Experimental | Drug: D3S-001, Drug: PembrolizumabPart 3a Arm A: Dose Expansion, D3S-001 in combination therapy administered orally in selected cancer type patients. Pembrolizumab administered intravenously. |
| D3S-001 and platinum doublet chemotherapy (cisplatin + pemetrexed or carboplatin + pemetrexed) | Experimental | Drug: D3S-001, Drug: Cisplatin, Drug: Carboplatin, Drug: PemetrexedPart 3a Arm B: Dose Expansion, D3S-001 in combination therapy administered orally in selected cancer type patients. Cisplatin + pemetrexed administered intravenously or Carboplatin + pemetrexed administered intravenously |
| D3S-001 and Cetuximab | Experimental | Drug: D3S-001, Drug: CetuximabPart 3b: Dose Expansion, D3S-001 in combination therapy administered orally in selected cancer type patients. Cetuximab administered intravenously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing.
- Subject must have documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood.
- Subject must have measurable disease per RECIST v1.1.
- Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subject must have adequate organ and marrow function within the screening period.
Key exclusion criteria (6 listed)
- Subject has any prior treatment with other treatments without adequate washout periods as defined in the protocol.
- Subject has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, uncontrolled or significant cardiovascular disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.
- Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).
- Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy.
- Concurrent participation in any clinical research study involving treatment with any investigational drug, radiotherapy, or surgery, except for the nontreatment phases of these studies (e.g., follow-up phase).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D3S-001Oral | Drug | D3S-001 and Cetuximab, D3S-001 and pembrolizumab, D3S-001 and platinum doublet chemotherapy (cisplatin + pemetrexed or carboplatin + pemetrexed), D3S-001 monotherapy |
| PembrolizumabIntravenous | Drug | D3S-001 and pembrolizumab |
| CisplatinIntravenous | Drug | D3S-001 and platinum doublet chemotherapy (cisplatin + pemetrexed or carboplatin + pemetrexed) |
| CarboplatinIntravenous | Drug | D3S-001 and platinum doublet chemotherapy (cisplatin + pemetrexed or carboplatin + pemetrexed) |
| PemetrexedIntravenous | Drug | D3S-001 and platinum doublet chemotherapy (cisplatin + pemetrexed or carboplatin + pemetrexed) |
| CetuximabIntravenous | Drug | D3S-001 and Cetuximab |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: From first dose until 30 days after the last dose (or specified in the protocol).
Number of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: From Cycle 1 Day 1 through Day 21. Each cycle is 21 days.
8 secondary outcomes
D3S-001 maximum observed plasma concentration (Cmax)
Time frame: Up to 24 months.
D3S-001 time to maximum plasma concentration (tmax)
Time frame: Up to 24 months.
D3S-001 half-life (t1/2)
Time frame: Up to 24 months.
D3S-001 area under the concentration-time curve (AUC)
Time frame: Up to 24 months.
Objective response rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Up to 24 months.
Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Up to 24 months.
Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Up to 24 months.
Disease Control Rate (DCR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame: Up to 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Derived from this study: PubMed 40301557Cho BC, Lu S, Lee MA, Song Z, Park JJ, Lim SM, Li Z, Zhao J, Richardson G, Zhang Y, Zhang J, Liu A, Loong HH, Chen C, Wang J, Shen Y, Fan Z, Chen Q, Wang H, Zhang J, Chen ZJ, Johnson ML, Mok T. D3S-001 in advanced solid tumors with KRASG12C mutations: a phase 1 trial. Nat Med. 2025 Aug;31(8):2768-2777. doi: 10.1038/s41591-025-03688-6. Epub 2025 Apr 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cheng Chen, MD study director
D3 Bio (Wuxi) Co., Ltd
52 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing D3S-001, Pembrolizumab and Cisplatin in people with KRAS P.G12C, run by D3 Bio (Wuxi) Co., Ltd at 52 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in China, United States, Spain, Australia, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Director (+86 21 61635900, D3bio_CT@d3bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) (time frame: From first dose until 30 days after the last dose (or specified in the protocol).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05410145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.