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New hope for HER2 cancers? early trial of D3L-001 begins

NCT ID NCT05957536

Disease control Sponsor: D3 Bio (Wuxi) Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This early-phase trial is testing a new drug called D3L-001 in 128 people with advanced HER2-positive solid tumors. The main goals are to check the drug's safety, find the right dose, and see early signs of whether it can shrink tumors. Participants receive D3L-001 through an IV, and the study is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
D3L-001 (an experimental biologic drug given intravenously)
What this could lead to
If this early trial shows promise, D3L-001 could become a new treatment option for people with HER2-positive cancers that have not responded to other therapies.
What could go wrong
This is a very early Phase 1 study with only 128 participants, focused on safety and dosing. It is too soon to know if D3L-001 will work or be safe for wider use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 128 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HER-2 positive advanced solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • D3 Bio Investigative Site

    TERMINATED

    Stanford, California, 94305, United States

  • D3 Bio Investigative Site

    TERMINATED

    Boston, Massachusetts, 02215, United States

  • D3 Bio Investigative Site

    RECRUITING

    New York, New York, 10065, United States

  • D3 Bio Investigative Site

    TERMINATED

    San Antonio, Texas, 78229, United States

  • D3 Bio Investigative Site

    RECRUITING

    Sydney, New South Wales, 2109, Australia

  • D3 Bio Investigative Site

    RECRUITING

    Malvern, Victoria, 3144, Australia

  • D3 Bio Investigative Site

    RECRUITING

    Harbin, Heilongjiang, 150088, China

  • D3 Bio Investigative Site

    RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

  • D3 Bio Investigative Site

    RECRUITING

    Hangzhou, Zhejiang, 310022, China