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NCT05410145 · ClinicalTrials.gov registry record · Phase 1
A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation
A Phase 1 study of Kras P.G12C, sponsored by D3 Bio (Wuxi) Co..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 442
- Enrollment target
- 20
- Study locations
NCT05410145: Recruiting Phase 1 study of Kras P.G12C, sponsored by D3 Bio (Wuxi) Co..
NCT05410145 is a Phase 1 study of Kras P.G12C that is actively recruiting participants, run by D3 Bio (Wuxi) Co.. The registered enrollment target is 442 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (637% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05410145, a Phase 1 study of Kras P.G12C, is actively recruiting participants, sponsored by D3 Bio (Wuxi) Co..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 442 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG D3S-001
Study Locations (20)
California
- D3 Bio Investigative Site 0402 - Orange
- D3 Bio Investigative Site 0407 - Palo Alto
Victoria
- D3 Bio Investigative Site 0101 - Malvern
- D3 Bio Investigative Site 0105 - Melbourne
Hubei
- D3 Bio Investigative Site 0309 - Wuhan
- D3 Bio Investigative Site 0312 - Wuhan
Colorado
- D3 Bio Investigative Site 0404 - Denver
Florida
- D3 Bio Investigative Site 0406 - Sarasota
Michigan
- D3 Bio Investigative Site 0401 - Detroit
Tennessee
- D3 Bio Investigative Site 0405 - Nashville
Texas
- D3 Bio Investigative Site 0403 - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 442 participants |
| Start Date | 2022-08-03 |
| Est. Completion | 2027-04 |
| Phase | Phase 1 |
What NCT05410145 shows while recruiting
NCT05410145 is an interventional study that assigns participants to a tested intervention. The registered 442 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (637% higher).
The record links to 1 condition, with Kras P.G12C appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT05410145 names 20 study sites across 17 states, led by California, Victoria, Hubei.
Frequently Asked Questions
What is clinical trial NCT05410145 about?
NCT05410145 is a clinical study titled "A Study 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 soli...
What is the current status of trial NCT05410145?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 442 participants. The study started on 2022-08-03. Estimated completion is 2027-04.
What conditions does trial NCT05410145 study?
This clinical trial studies the following conditions: Kras P.G12C.
What interventions are being tested in trial NCT05410145?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), D3S-001 (DRUG).
Who is sponsoring clinical trial NCT05410145?
This trial is sponsored by D3 Bio (Wuxi) Co., which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05410145 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Michigan, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05410145's enrollment target sits among peer trials
442 59th of 2000 higher than 1,941 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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