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Trial Title:
A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors
NCT ID:
NCT05957536
Condition:
HER-2 Positive Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
HER-2 Positive
Advanced Solid Tumors
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
D3L-001
Description:
Intravenous administration
Arm group label:
D3L-001
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Subject must have documented HER2 positivity (determined by immunohistochemistry
[IHC], in situ hybridization [ISH], Next Generation Sequencing [NGS] or other
analysis techniques as appropriate).
- Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0
or 1.
- Subject must have left ventricular ejection fraction (LVEF) ≥50% by either
echocardiography (ECHO) or multiple-gated acquisition (MUGA) within the screening
period.
- Subject must have adequate organ and marrow function within the screening period.
Exclusion Criteria:
- Subject has any prior treatment with anti-CD47 or SIRPα agent.
- Subject has major surgery or radiotherapy, immunostimulatory agents, investigational
agents, or any other anticancer treatment including chemotherapy, targeted therapy,
biologics that is not completed 28 days before first dose of study medication.
- Subject has immunosuppressive medication that is not completed 14 days before the
first dose of study medication.
- Subject has uncontrolled intercurrent illness that would limit compliance with study
requirements, substantially increase risk of incurring AEs, or compromise the
ability of the subject to give written informed consent.
- Subject has unresolved treatment-related toxicities from previous anticancer therapy
of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).
- Judgment by the Investigator that the subject should not participate in the study if
the subject is unlikely to comply with study procedures, restrictions, and
requirements.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
D3 Bio Investigative Site
Address:
City:
Stanford
Zip:
94305
Country:
United States
Status:
Recruiting
Facility:
Name:
D3 Bio Investigative Site
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
D3 Bio Investigative Site
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
D3 Bio Investigative Site
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
D3 Bio Investigative Site
Address:
City:
Sydney
Zip:
2109
Country:
Australia
Status:
Recruiting
Facility:
Name:
D3 Bio Investigative Site
Address:
City:
Malvern
Zip:
3144
Country:
Australia
Status:
Recruiting
Facility:
Name:
D3 Bio Investigative Site
Address:
City:
Harbin
Zip:
150088
Country:
China
Status:
Recruiting
Facility:
Name:
D3 Bio Investigative Site
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Facility:
Name:
D3 Bio Investigative Site
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Start date:
September 19, 2023
Completion date:
March 11, 2026
Lead sponsor:
Agency:
D3 Bio (Wuxi) Co., Ltd
Agency class:
Industry
Source:
D3 Bio (Wuxi) Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05957536
