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NCT05957536 · ClinicalTrials.gov registry record · Phase 1
A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors
A Phase 1 study of HER-2 Positive Advanced Solid Tumors, sponsored by D3 Bio (Wuxi) Co..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 128
- Enrollment target
- 9
- Study locations
NCT05957536: Recruiting Phase 1 study of HER-2 Positive Advanced Solid Tumors, sponsored by D3 Bio (Wuxi) Co..
NCT05957536 is a Phase 1 study of HER-2 Positive Advanced Solid Tumors that is actively recruiting participants, run by D3 Bio (Wuxi) Co.. The registered enrollment target is 128 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (113% higher). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05957536, a Phase 1 study of HER-2 Positive Advanced Solid Tumors, is actively recruiting participants, sponsored by D3 Bio (Wuxi) Co..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 128 participants
- Enrollment target
- 9
- Study locations
Study Summary
This first-in-human (FIH) study, multi-center, open-label, dose escalation and dose expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary anti-tumor activity of D3L-001 in subjects with HER2-positive advanced solid tumors.
Conditions Studied
Interventions
- BIOLOGICAL D3L-001
Study Locations (9)
California
- D3 Bio Investigative Site - Stanford
Massachusetts
- D3 Bio Investigative Site - Boston
New York
- D3 Bio Investigative Site - New York
Texas
- D3 Bio Investigative Site - San Antonio
New South Wales
- D3 Bio Investigative Site - Sydney
Victoria
- D3 Bio Investigative Site - Malvern
Heilongjiang
- D3 Bio Investigative Site - Harbin
Shanghai Municipality
- D3 Bio Investigative Site - Shanghai
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2023-09-19 |
| Est. Completion | 2028-12-19 |
| Phase | Phase 1 |
What NCT05957536 shows while recruiting
NCT05957536 is an interventional study that assigns participants to a tested intervention. The registered 128 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 (113% higher).
The record links to 1 condition, with HER-2 Positive Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which D3L-001 is the first listed.
NCT05957536 lists 9 locations in 9 states (California, Massachusetts, New York).
Frequently Asked Questions
What is clinical trial NCT05957536 about?
NCT05957536 is a clinical study titled "A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors". This first-in-human (FIH) study, multi-center, open-label, dose escalation and dose expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary anti-tumor activity of D3L-001 in subjects with HER2-positive advanced solid...
What is the current status of trial NCT05957536?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 128 participants. The study started on 2023-09-19. Estimated completion is 2028-12-19.
What conditions does trial NCT05957536 study?
This clinical trial studies the following conditions: HER-2 Positive Advanced Solid Tumors.
What interventions are being tested in trial NCT05957536?
The interventions under investigation include: D3L-001 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05957536?
This trial is sponsored by D3 Bio (Wuxi) Co., which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05957536 being conducted?
This trial has 9 study locations across California, Massachusetts, New York, Texas, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05957536's enrollment target sits among peer trials
128 452nd of 2000 higher than 1,542 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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