Testing D3L-001 for HER2-Positive Advanced Solid Tumors
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.
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 |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | D3 Bio (Wuxi) Co., Ltd Industry-sponsored |
| Locations | 9 sites (Stanford, California and 8 other locations) |
| Trial ID | NCT05957536 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with documented HER2 positivity and an ECOG performance status of 0 or 1.
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.
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 performed: While this approach is novel in the context of D3L-001, similar studies targeting HER2-positive tumors have shown promising results in the past.
Eligibility criteria
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 this trial is running
Stanford, California and 8 other locations
- D3 Bio Investigative Site — Stanford, California, United States (Recruiting)
- D3 Bio Investigative Site — Boston, Massachusetts, United States (Recruiting)
- D3 Bio Investigative Site — New York, New York, United States (Recruiting)
- D3 Bio Investigative Site — San Antonio, Texas, United States (Terminated)
- 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)
Study contacts
- Study coordinator: Medical Director
- Email: D3bio_CT@d3bio.com
- Phone: +86 21 61635900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.