A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Number of Participants With Adverse Events (AEs) — From first dose until 30 days after the last dose (or specified in the protocol).
- Number of Participants With Dose-Limiting Toxicities (DLTs) — From Cycle 1 Day 1 through Day 21. Each cycle is 21 days.
Trial sites (52)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
📄 Keytruda (pembrolizumab) drug profile →More D3 Bio (Wuxi) Co., Ltd trials in South Korea
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 South Korea