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

NCT05957536 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-03-13

No results posted yet for this study

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

BIOLOGICAL

D3L-001

Intravenous administration

Sponsors & Collaborators

  • D3 Bio (Wuxi) Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-19
Primary Completion
2028-12-19
Completion
2028-12-19
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05957536 on ClinicalTrials.gov