A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors
Recruiting now · Phase 1
Conditions studied: HER-2 Positive Advanced Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT05957536
- Run by
- D3 Bio (Wuxi) Co., Ltd
- People needed
- 128
- Starts
- 2023-09-19
- Expected to finish
- 2028-12-19
- Last updated by the study team
- 2026-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Subject has any prior treatment with anti-CD47 or SIRPα agent.
- Subject has any prior treatment without adequate washout periods as defined in the protocol.
- 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.
Where it is running
- D3 Bio Investigative Site — Hangzhou, Zhejiang, China (enrolling)
- D3 Bio Investigative Site — Boston, Massachusetts, United States (enrolling)
- D3 Bio Investigative Site — New York, New York, United States (enrolling)
- D3 Bio Investigative Site — Stanford, California, United States (enrolling)
- D3 Bio Investigative Site — Sydney, New South Wales, Australia (enrolling)
- D3 Bio Investigative Site — Malvern, Victoria, Australia (enrolling)
- D3 Bio Investigative Site — Harbin, Heilongjiang, China (enrolling)
- D3 Bio Investigative Site — Shanghai, Shanghai Municipality, China (enrolling)
- D3 Bio Investigative Site — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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