Clinical Trial

A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors

Recruiting Phase 1
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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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2023-07-20; most recent amendment 2026-03-11.
Status change: Not Yet Recruiting → Recruiting 2023-10-16
Trial Details
NCT Number NCT05957536
Lead Sponsor D3 Bio (Wuxi) Co., Ltd
Conditions HER-2 Positive Advanced Solid Tumors
Enrollment 128 participants
Start Date 2023-09-19
Primary Completion 2028-12-19 (estimated)
Study Completion 2028-12-19 (estimated)
Updated on ClinicalTrials.gov 2026-03-13