Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07456046 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation.
A Phase 1 study, sponsored by D3 Bio (Wuxi) Co..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT07456046: Recruiting Phase 1 study, sponsored by D3 Bio (Wuxi) Co..
NCT07456046 is a Phase 1 study that is actively recruiting participants, run by D3 Bio (Wuxi) Co.. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07456046, a Phase 1 study, is actively recruiting participants, sponsored by D3 Bio (Wuxi) Co..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
This is a first-in-human (FIH) multicenter, open-label, dose-escalation Phase 1 clinical trial to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of D3S-003 in participants with advanced KRAS p.G12D mutant solid tumors.
Interventions
- DRUG D3S-003
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2026-05-29 |
| Est. Completion | 2028-01-11 |
| Phase | Phase 1 |
What NCT07456046 shows while recruiting
NCT07456046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 1 intervention - of which D3S-003 is the first listed.
NCT07456046 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07456046 about?
NCT07456046 is a clinical study titled "A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation.". This is a first-in-human (FIH) multicenter, open-label, dose-escalation Phase 1 clinical trial to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of D3S-003 in participants with advanced KRAS p.G12D mutant solid tumors.
What is the current status of trial NCT07456046?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2026-05-29. Estimated completion is 2028-01-11.
What interventions are being tested in trial NCT07456046?
The interventions under investigation include: D3S-003 (DRUG).
Who is sponsoring clinical trial NCT07456046?
This trial is sponsored by D3 Bio (Wuxi) Co., which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07456046's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02852213 · 42 participants · Phase 1
A Single-Stage, Adaptive, Open-label, Dose Escalation Safety and Efficacy Study of AADC Deficiency in Pediatric Patients
- NCT03136146 · 42 participants · Phase 2
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia
- NCT03178149 · 42 participants · Phase 1
A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
- NCT03663530 · 42 participants · NA
Circadian Misalignment and Energy Balance
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI