drugset / Trial / NCT07667842
Study of D3L-002 in Subjects With Advanced Solid Tumors
NaSequentialOpen-labelTreatment
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).
Timeline
- Start
- 2026-07-18
- Primary completion
- 2027-11-12
- Completion
- 2028-02-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | D3L-002 | Unknown | — | Intravenous |
Indications
No indication recorded.