RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation

Sponsor: D3 Bio (Wuxi) Co., Ltd • ClinicalTrials.gov ID: NCT05410145

Registry updated: 2026-09-15

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Description

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.

Interventions

D3S-001 (Drug)
Oral
Pembrolizumab (Drug)
Intravenous
Cisplatin (Drug)
Intravenous
Carboplatin (Drug)
Intravenous
Pemetrexed (Drug)
Intravenous
Cetuximab (Drug)
Intravenous

Eligibility criteria

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

Conditions

KRAS P.G12C

Locations

D3 Bio Investigative Site 0402 — Orange, California, United States
D3 Bio Investigative Site 0407 — Palo Alto, California, United States
D3 Bio Investigative Site 0404 — Denver, Colorado, United States
D3 Bio Investigative Site 0406 — Sarasota, Florida, United States
D3 Bio Investigative Site 0401 — Detroit, Michigan, United States
D3 Bio Investigative Site 0405 — Nashville, Tennessee, United States
D3 Bio Investigative Site 0403 — Houston, Texas, United States
D3 Bio Investigative Site 0102 — Sydney, New South Wales, Australia
D3 Bio Investigative Site 0101 — Malvern, Victoria, Australia
D3 Bio Investigative Site 0105 — Melbourne, Victoria, Australia
D3 Bio Investigative Site 0103 — Nedlands, Western Australia, Australia
D3 Bio Investigative Site 0104 — Bedford Park, Australia
D3 Bio Investigative Site 0314 — Hefei, Anhui, China
D3 Bio Investigative Site 0303 — Beijing, Beijing Municipality, China
D3 Bio Investigative Site 0306 — Guangzhou, Guangdong, China
D3 Bio Investigative Site 0305 — Hangzhou, Hangzhou, China
D3 Bio Investigative Site 0307 — Harbin, Heilongjiang, China
D3 Bio Investigative Site 0309 — Wuhan, Hubei, China
D3 Bio Investigative Site 0312 — Wuhan, Hubei, China
D3 Bio Investigative Site 0315 — Changsha, Hunan, China
D3 Bio Investigative Site 0313 — Zhengzhou, Hunan, China
D3 Bio Investigative Site 0304 — Nanchang, Jiangxi, China
D3 Bio Investigative Site 0302 — Shenyang, Liaoning, China
D3 Bio Investigative Site 0310 — Jinan, Shandong, China
D3 Bio Investigative Site 0301 — Shanghai, Shanghai Municipality, China
D3 Bio Investigative Site 0308 — Shanghai, Shanghai Municipality, China
D3 Bio Investigative Site 0316 — Chengdu, Sichuan, China
D3 Bio Investigative Site 0311 — Hangzhou, Zhejiang, China
D3 Bio Investigative Site 0804 — Bordeaux, France
D3 Bio Investigative Site 0803 — Lyon, France
D3 Bio Investigative Site 0801 — Rennes, France
D3 Bio Investigative Site 0802 — Villejuif, France
D3 Bio Investigative Site 1003 — Cologne, North Rhine-Westphalia, Germany
D3 Bio Investigative Site 1002 — Hamburg, Germany
D3 Bio Investigative Site 0501 — Shatin, Hong Kong
D3 Bio Investigative Site 0905 — Candiolo, Italy
D3 Bio Investigative Site 0902 — Milan, Italy
D3 Bio Investigative Site 0904 — Naples, Italy
D3 Bio Investigative Site 0901 — Rome, Italy
D3 Bio Investigative Site 0903 — Siena, Italy
D3 Bio Investigative Site 0601 — Kashiwa, Japan
D3 Bio Investigative Site 0602 — Tokyo, Japan
D3 Bio Investigative Site 0204 — Cheongju-si, North Chungcheong, South Korea
D3 Bio Investigative Site 0202 — Seoul, South Korea
D3 Bio Investigative Site 0203 — Seoul, South Korea
D3 Bio Investigative Site 0201 — Seoul, South Korea
D3 Bio Investigative Site 0706 — Barcelona, Spain
D3 Bio Investigative Site 0701 — Barcelona, Spain
D3 Bio Investigative Site 0704 — Madrid, Spain
D3 Bio Investigative Site 0705 — Madrid, Spain
D3 Bio Investigative Site 0703 — Valencia, Spain
D3 Bio Investigative Site 0702 — Valencia, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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