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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 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. The trial reports 20 study locations across 17 states.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05410145
The ClinicalTrials.gov registry entry for NCT05410145 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 442 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is D3 Bio (Wuxi) Co., which has 4 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 17 distinct geographic areas - top geographies include 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.
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Related
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