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A Study of D3L-001 for HER2-Positive Advanced Solid Tumors

This study is testing a new treatment called D3L-001 given intravenously (into a vein) for people with HER2-positive advanced solid tumors. HER2 positivity means your tumor has a specific protein that can be targeted. The main goals are to find out how safe D3L-001 is, what dose can be given safely, and if it shows any early signs of shrinking tumors. You might be able to join if you are 18 or older, have HER2-positive advanced solid tumors, and a good general health status (ECOG performance status of 0 or 1). This study is currently enrolling 128 participants.

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know you are receiving D3L-001. It will involve a dose escalation and expansion to find the right dose and assess safety.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the start of the study until 30 days after your last dose of D3L-001.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05957536

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
D3 Bio (Wuxi) Co., Ltd
~128 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:D3L-001

At a glance

Recruiting sites
8 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Adverse Events (AEs)
Measured over Screening until Safety Follow Up visit (30 days after the last dose)
+1 more outcome measured

Conditions

HER-2 Positive Advanced Solid Tumors

Explore related trials

Solid NeoplasmERBB2 Gene

Where it's being run

9 sites across 9 states
California1
Massachusetts1
New York1
Texas1
New South Wales1
Victoria1
Heilongjiang1
Shanghai Municipality1

Who to contact

Medical Director
[email protected]
+86 21 61635900
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants With Adverse Events (AEs)Screening until Safety Follow Up visit (30 days after the last dose)
  • Maximum Tolerated Dose based on Dose-Limiting Toxicities (DLTs)At the end of Cycle 1 (each cycle is 21 days).