Testing D3L-001 for HER2-Positive Advanced Solid Tumors
Official title: A Phase 1, Open-label Dose Escalation and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3L-001 Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors.
Run by D3 Bio (Wuxi) Co., Ltd · NCT05957536 · Data updated 2026-11-12
This study is testing a new treatment called D3L-001 to see if it is safe and effective for people with advanced HER2-positive solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | D3 Bio (Wuxi) Co., Ltd Industry-sponsored |
| Locations | 9 sites (Stanford, California and 8 other locations) |
| Status | Recruiting |
| Started | September 19, 2023 |
| Main results expected | December 19, 2028 |
| Study ends | December 19, 2028 |
| Registry record updated | August 28, 2026 |
| Trial ID | NCT05957536 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with documented HER2 positivity and an ECOG performance status of 0 or 1.
✕Probably not a fit
Patients who have previously received anti-CD47 or SIRPα agents or those with recent major surgeries or other anticancer treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a first-in-human, multi-center, open-label Phase I study designed to evaluate the safety and tolerability of D3L-001 in patients with HER2-positive advanced solid tumors. The study will involve dose escalation and expansion phases to assess pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of the treatment. Participants will be closely monitored for any adverse effects and overall response to the therapy.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with HER2-positive advanced solid tumors.
How similar studies have gone: While this approach is novel in the context of D3L-001, similar studies targeting HER2-positive tumors have shown promising results in the past.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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D3 Bio Investigative Site
New York, New York, United States Recruiting -
D3 Bio Investigative Site
Sydney, New South Wales, Australia Recruiting -
D3 Bio Investigative Site
Malvern, Victoria, Australia Recruiting -
D3 Bio Investigative Site
Harbin, Heilongjiang, China Recruiting -
D3 Bio Investigative Site
Shanghai, Shanghai Municipality, China Recruiting -
D3 Bio Investigative Site
Hangzhou, Zhejiang, China Recruiting
Show 3 more locations
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D3 Bio Investigative Site
Stanford, California, United States Terminated -
D3 Bio Investigative Site
Boston, Massachusetts, United States Terminated -
D3 Bio Investigative Site
San Antonio, Texas, United States Terminated
Study contacts
- Study coordinator: Medical Director
- Email: D3bio_CT@d3bio.com
- Phone: +86 21 61635900
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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D3L-002 in Advanced Solid Tumors (Phase 1)
D3L-002 is being tested in adults with advanced solid tumors to see if it is safe, tolerable, and shows any signs of benefit when given in escalating doses.
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Testing D3S-003 alone in people with advanced solid tumors that have a KRAS p.G12D mutation
This trial will test whether D3S-003 given by itself is safe and shows signs of benefit for people with advanced solid tumors that carry a KRAS p.G12D mutation who have already tried at least one standard therapy.
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Testing D3S-002 for advanced solid tumors with specific mutations
This study is testing a new oral medication called D3S-002 to see if it can help adults with advanced solid tumors that have specific mutations and haven't responded to other treatments.
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Treatment for advanced solid tumors with a specific KRAS mutation
This study is testing a new oral treatment called D3S-001 for people with advanced solid tumors that have a specific KRAS mutation to see if it works and is safe.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.