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Clinical Trials in the USA / NCT05410145
Recruiting Phase 1/2

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

NCT05410145 · tracked via the Priya Life Science USA tracker
Sponsor
D3 Bio (Wuxi) Co., Ltd
Phase
Phase 1/2
Started
2022-08-03
Last updated
2026-09-15

Condition(s) studied

KRAS P.G12C

Investigational drug(s) / intervention(s)

D3S-001PembrolizumabCisplatinCarboplatinPemetrexedCetuximab

D3S-001: Oral

Pembrolizumab: Intravenous

Cisplatin: Intravenous

Carboplatin: Intravenous

Pemetrexed: Intravenous

Cetuximab: Intravenous

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (52)

FacilityCityRegionStatus
D3 Bio Investigative Site 0402 Orange California Recruiting
D3 Bio Investigative Site 0407 Palo Alto California Recruiting
D3 Bio Investigative Site 0404 Denver Colorado Recruiting
D3 Bio Investigative Site 0406 Sarasota Florida Recruiting
D3 Bio Investigative Site 0401 Detroit Michigan Recruiting
D3 Bio Investigative Site 0405 Nashville Tennessee Recruiting
D3 Bio Investigative Site 0403 Houston Texas Recruiting
D3 Bio Investigative Site 0102 Sydney New South Wales Recruiting
D3 Bio Investigative Site 0101 Malvern Victoria Recruiting
D3 Bio Investigative Site 0105 Melbourne Victoria Recruiting
D3 Bio Investigative Site 0103 Nedlands Western Australia Recruiting
D3 Bio Investigative Site 0104 Bedford Park Australia Recruiting
D3 Bio Investigative Site 0314 Hefei Anhui Recruiting
D3 Bio Investigative Site 0303 Beijing Beijing Municipality Recruiting
D3 Bio Investigative Site 0306 Guangzhou Guangdong Recruiting
D3 Bio Investigative Site 0305 Hangzhou Hangzhou Recruiting
D3 Bio Investigative Site 0307 Harbin Heilongjiang Recruiting
D3 Bio Investigative Site 0309 Wuhan Hubei Recruiting
D3 Bio Investigative Site 0312 Wuhan Hubei Recruiting
D3 Bio Investigative Site 0315 Changsha Hunan Recruiting
D3 Bio Investigative Site 0313 Zhengzhou Hunan Recruiting
D3 Bio Investigative Site 0304 Nanchang Jiangxi Recruiting
D3 Bio Investigative Site 0302 Shenyang Liaoning Recruiting
D3 Bio Investigative Site 0310 Jinan Shandong Recruiting
D3 Bio Investigative Site 0301 Shanghai Shanghai Municipality Recruiting
D3 Bio Investigative Site 0308 Shanghai Shanghai Municipality Recruiting
D3 Bio Investigative Site 0316 Chengdu Sichuan Recruiting
D3 Bio Investigative Site 0311 Hangzhou Zhejiang Recruiting
D3 Bio Investigative Site 0804 Bordeaux France Recruiting
D3 Bio Investigative Site 0803 Lyon France Recruiting
D3 Bio Investigative Site 0801 Rennes France Recruiting
D3 Bio Investigative Site 0802 Villejuif France Recruiting
D3 Bio Investigative Site 1003 Cologne North Rhine-Westphalia Recruiting
D3 Bio Investigative Site 1002 Hamburg Germany Recruiting
D3 Bio Investigative Site 0501 Shatin Hong Kong Recruiting
D3 Bio Investigative Site 0905 Candiolo Italy Recruiting
D3 Bio Investigative Site 0902 Milan Italy Recruiting
D3 Bio Investigative Site 0904 Naples Italy Recruiting
D3 Bio Investigative Site 0901 Rome Italy Recruiting
D3 Bio Investigative Site 0903 Siena Italy Recruiting

+ 12 more sites — see the full list on the official registry below.

On this site

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More D3 Bio (Wuxi) Co., Ltd trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05410145 on ClinicalTrials.gov ↗ ← All trials in the USA