> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-d3s-001-monotherapy-or-combination-therapy-in-3f92b85b-6ea9-4de9-b404-ba6bf5b05470 > Record changed: 2026-10-13 # A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation NCT05410145 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) Participants 442 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) Lead sponsor D3 Bio (Wuxi) Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) Start date 2022-08-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) Number of sites 52 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **Short title** A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) ## Dates **Completion date** 2027-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **First posted** 2022-06-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **Registry last updated** 2026-03-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **Primary completion date** 2027-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **Start date** 2022-08-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) ## Size and sites **Participants** 442 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **Planned participants** 442 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **Protocol amendments** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **Number of sites** 52 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **Lead sponsor** D3 Bio (Wuxi) Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) ## Identifiers **Registry ID** NCT05410145 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **ClinicalTrials.gov ID** NCT05410145 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) ## Outcomes ### Primary outcomes 1. Number of Participants With Adverse Events (AEs) Timeframe: From first dose until 30 days after the last dose (or specified in the protocol). 2. Number of Participants With Dose-Limiting Toxicities (DLTs) Timeframe: From Cycle 1 Day 1 through Day 21\. Each cycle is 21 days. ### Secondary outcomes 1. D3S-001 maximum observed plasma concentration (Cmax) Timeframe: Up to 24 months. 2. D3S-001 time to maximum plasma concentration (tmax) Timeframe: Up to 24 months. 3. D3S-001 half-life (t1/2) Timeframe: Up to 24 months. 4. D3S-001 area under the concentration-time curve (AUC) Timeframe: Up to 24 months. 5. Objective response rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) Timeframe: Up to 24 months. 6. Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) Timeframe: Up to 24 months. 7. Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) Timeframe: Up to 24 months. 8. Disease Control Rate (DCR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) Timeframe: Up to 24 months. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Inclusion: - 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. Exclusion: - 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) ## Sites - D3 Bio Investigative Site 0402Orange, United StatesRecruiting - D3 Bio Investigative Site 0407Palo Alto, United StatesRecruiting - D3 Bio Investigative Site 0404Denver, United StatesRecruiting - D3 Bio Investigative Site 0406Sarasota, United StatesRecruiting - D3 Bio Investigative Site 0401Detroit, United StatesRecruiting - D3 Bio Investigative Site 0405Nashville, United StatesRecruiting - D3 Bio Investigative Site 0403Houston, United StatesRecruiting - D3 Bio Investigative Site 0102Sydney, AustraliaRecruiting - D3 Bio Investigative Site 0101Malvern, AustraliaRecruiting - D3 Bio Investigative Site 0105Melbourne, AustraliaRecruiting - D3 Bio Investigative Site 0103Nedlands, AustraliaRecruiting - D3 Bio Investigative Site 0104Bedford Park, AustraliaRecruiting - D3 Bio Investigative Site 0303Beijing, ChinaRecruiting - D3 Bio Investigative Site 0306Guangzhou, ChinaRecruiting - D3 Bio Investigative Site 0305Hangzhou, ChinaRecruiting - D3 Bio Investigative Site 0307Harbin, ChinaRecruiting - D3 Bio Investigative Site 0309Wuhan, ChinaRecruiting - D3 Bio Investigative Site 0312Wuhan, ChinaRecruiting - D3 Bio Investigative Site 0304Nanchang, ChinaRecruiting - D3 Bio Investigative Site 0302Shenyang, ChinaRecruiting - D3 Bio Investigative Site 0310Jinan, ChinaRecruiting - D3 Bio Investigative Site 0301Shanghai, ChinaRecruiting - D3 Bio Investigative Site 0308Shanghai, ChinaRecruiting - D3 Bio Investigative Site 0316Chengdu, ChinaRecruiting - D3 Bio Investigative Site 0311Hangzhou, ChinaRecruiting And 27 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) ## References - PubMed 40301557 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40301557/) Related publication ### Other registry identifiers (2) - 2023 - 2023-508517-16 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05410145) ## Related records ### Drugs (6) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) - [Cisplatin](https://trialight.com/data/asset/cisplatin-e039621a-d679-4740-88ac-94842bf4a91e.md) - [D3S-001](https://trialight.com/data/asset/d3s-001-c4b833cb-06d8-4cff-9616-d15202b34e55.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Pemetrexed](https://trialight.com/data/asset/pemetrexed-2221859e-676b-4d76-97df-e11f3f9664a1.md) ### Lead sponsors (1) - [D3 Bio (Wuxi) Co., Ltd](https://trialight.com/data/company/d3-bio-wuxi-co-ltd-07cfa35a-af51-4963-b3d5-e87edcacc57a.md) ### Targets (5) - [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [GART](https://trialight.com/data/target/gart-01a731ec-9c88-556f-8fc6-2217fab015bc.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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