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A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors
Sponsor: D3 Bio (Wuxi) Co., Ltd
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.
Official title: A Phase 1, Open-label Dose Escalation and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3L-001 Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
128
Start Date
2023-09-19
Completion Date
2028-12-19
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
D3L-001
Intravenous administration
Locations (9)
D3 Bio Investigative Site
Stanford, California, United States
D3 Bio Investigative Site
Boston, Massachusetts, United States
D3 Bio Investigative Site
New York, New York, United States
D3 Bio Investigative Site
San Antonio, Texas, United States
D3 Bio Investigative Site
Sydney, New South Wales, Australia
D3 Bio Investigative Site
Malvern, Victoria, Australia
D3 Bio Investigative Site
Harbin, Heilongjiang, China
D3 Bio Investigative Site
Shanghai, Shanghai Municipality, China
D3 Bio Investigative Site
Hangzhou, Zhejiang, China