NCT05957536

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

A Phase 1, Open-label Dose Escalation and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3L-001 Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: D3 Bio (Wuxi) Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HER-2 Positive Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	D3L-001	Intravenous administration

Timeline

• Start date: 2023-09-19
• Primary completion: 2028-12-19
• Completion: 2028-12-19
• First posted: 2023-07-24
• Last updated: 2026-03-13

Locations

9 sites across 3 countries: United States, Australia, China

Regulatory

• FDA-regulated drug study