New drug D3L-001 enters first human trial for Hard-to-Treat cancers

NCT ID NCT05957536

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

First seen Mar 17, 2026

Summary

This early-phase study is testing a new drug called D3L-001 in people with advanced solid tumors that have high levels of a protein called HER2. The main goals are to check the drug's safety, find the best dose, and see how the body processes it. About 128 participants will receive D3L-001 intravenously, and researchers will monitor for side effects and any signs of tumor shrinkage.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

D3 Bio Investigative Site
RECRUITING

Stanford, California, 94305, United States
D3 Bio Investigative Site
RECRUITING

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

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 (a biologic drug given intravenously)

What this could lead to

If it works, this could point toward a new treatment option for people with HER2-positive advanced solid tumors that have not responded to other therapies.

What could go wrong

This is a very early (Phase 1) study focused on safety and dosing, so it is not yet known if D3L-001 will shrink tumors or improve survival. Side effects are possible, and the drug may not work as hoped.

As listed by the trial registrant

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

HER-2 POSITIVE ADVANCED SOLID TUMORS