Clinical Trial

Study of D3L-002 in Subjects With Advanced Solid Tumors

Not Yet Recruiting Phase 1
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Summary
This is a first-in-human, multicenter, open-label, single-arm, dose-escalation Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of D3L-002 monotherapy in subjects with advanced solid tumors. D3L-002 will be administered as an intravenous infusion every 3 weeks (Q3W) in 21-day cycles. Approximately 24 subjects will be enrolled. Dose escalation will follow a Bayesian Optimal Interval (BOIN) design to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).
Trial Details
NCT Number NCT07667842
Lead Sponsor D3 Bio (Wuxi) Co., Ltd
Conditions Advanced Solid Tumor
Enrollment 24 participants
Start Date 2026-07-18
Primary Completion 2027-11-12 (estimated)
Study Completion 2028-02-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-25