NCT05957536 A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors
| NCT ID | NCT05957536 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | D3 Bio (Wuxi) Co., Ltd |
| Condition | HER-2 Positive Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2023-09-19 |
| Primary Completion | 2028-12-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 128 participants in total. It began in 2023-09-19 with a primary completion date of 2028-12-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This first-in-human (FIH) study, multi-center, open-label, dose escalation and dose expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary anti-tumor activity of D3L-001 in subjects with HER2-positive advanced solid tumors.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05957536 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HER-2 Positive Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05957536 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05957536 currently recruiting?
Yes, NCT05957536 is actively recruiting participants. Contact the research team at D3bio_CT@d3bio.com for enrollment information.
Where is the NCT05957536 trial being conducted?
This trial is being conducted at Stanford, United States, Boston, United States, New York, United States, San Antonio, United States and 5 additional locations.
Who is sponsoring the NCT05957536 clinical trial?
NCT05957536 is sponsored by D3 Bio (Wuxi) Co., Ltd. The trial plans to enroll 128 participants.