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RECRUITING
NCT05957536
PHASE1

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

Sponsor: D3 Bio (Wuxi) Co., Ltd

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2023-09-19

Completion Date

2028-12-19

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

BIOLOGICAL

D3L-001

Intravenous administration

Locations (9)

D3 Bio Investigative Site

Stanford, California, United States

D3 Bio Investigative Site

Boston, Massachusetts, United States

D3 Bio Investigative Site

New York, New York, United States

D3 Bio Investigative Site

San Antonio, Texas, United States

D3 Bio Investigative Site

Sydney, New South Wales, Australia

D3 Bio Investigative Site

Malvern, Victoria, Australia

D3 Bio Investigative Site

Harbin, Heilongjiang, China

D3 Bio Investigative Site

Shanghai, Shanghai Municipality, China

D3 Bio Investigative Site

Hangzhou, Zhejiang, China