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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 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. The trial reports 9 study locations across 9 states.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05957536
The ClinicalTrials.gov registry entry for NCT05957536 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 128 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 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 reports 9 study locations spanning 9 distinct geographic areas - top geographies include 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.
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