Actively Recruiting
A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors
Led by D3 Bio (Wuxi) Co., Ltd · Updated on 2026-03-13
128
Participants Needed
9
Research Sites
274 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented HER2 positivity confirmed by immunohistochemistry, in situ hybridization, next generation sequencing, or similar methods
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Left ventricular ejection fraction (LVEF) of 50% or higher by echocardiography or multiple-gated acquisition scan within screening period
- Adequate organ and marrow function within screening period
You will not qualify if you...
- Prior treatment with anti-CD47 or SIRPα agents
- Prior treatments without adequate washout periods as defined in the protocol
- Use of immunosuppressive medication not completed at least 14 days before first study dose
- Uncontrolled illnesses that limit compliance, increase risk of adverse events, or affect ability to consent
- Unresolved treatment-related toxicities from prior anticancer therapy of grade 2 or higher (except vitiligo or alopecia)
- Investigator judgment that participant is unlikely to comply with study procedures, restrictions, or requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
D3 Bio Investigative Site
Stanford, California, United States, 94305
Actively Recruiting
2
D3 Bio Investigative Site
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
D3 Bio Investigative Site
New York, New York, United States, 10065
Actively Recruiting
4
D3 Bio Investigative Site
San Antonio, Texas, United States, 78229
Terminated
5
D3 Bio Investigative Site
Sydney, New South Wales, Australia, 2109
Actively Recruiting
6
D3 Bio Investigative Site
Malvern, Victoria, Australia, 3144
Actively Recruiting
7
D3 Bio Investigative Site
Harbin, Heilongjiang, China, 150088
Actively Recruiting
8
D3 Bio Investigative Site
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
9
D3 Bio Investigative Site
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
M
Medical Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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