RECRUITING Phase 1 ClinicalTrials.gov

A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors

Sponsor: D3 Bio (Wuxi) Co., Ltd • ClinicalTrials.gov ID: NCT05957536

Registry updated: 2026-08-28

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Description

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.

Interventions

D3L-001 (Biological)
Intravenous administration

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 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.

Conditions

HER-2 Positive Advanced Solid Tumors

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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