Status: Recruiting
A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors
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.
Participants needed: 128
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: D3 Bio (Wuxi) Co., LtdUpdated: Mar 13, 2026Locations: 9
Eligibility criteria
Subject must have documented HER2 positivity (determined by immunohistochemistry... [+3]
Subject has any prior treatment with anti-CD47 or SIRPα agent. [+5]