Recruiting
Phase 1

D3L-001

Sponsor:

D3 Bio (Wuxi) Co., Ltd

Code:

NCT05957536

Conditions

HER-2 Positive Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

D3L-001

Study Details

Brief 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

Study ID

NCT05957536

Start date

Sep 19, 2023

Status verified date

Aug, 2026

Completion date

Dec 19, 2028

Anticipated

Primary completion date

Dec 19, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subject must have documented HER2 positivity (determined by immunohistochemistry \[IHC\], in situ hybridization \[ISH\], Next Generation Sequencing \[NGS\] or other analysis techniques as appropriate).
  • Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Subject must have left ventricular ejection fraction (LVEF) ≥50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within the screening period.
  • Subject must have adequate organ and marrow function within the screening period.

Exclusion Criteria:

  • Subject has any prior treatment with anti-CD47 or SIRPα agent.
  • Subject has any prior treatment without adequate washout periods as defined in the protocol.
  • Subject has immunosuppressive medication that is not completed 14 days before the first dose of study medication.
  • Subject has uncontrolled intercurrent illness that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.
  • Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).
  • Judgment by the Investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions, and requirements.

Study Design

Enrollment

128 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: D3L-001

Part 1 Dose Escalation in subjects with HER2-positive advanced solid tumors

  • Cohort 1 (starting dose)
  • Cohort 2
  • Cohort 3
  • Cohort 4
  • Cohort 5
  • Cohort 6
  • Cohort 7
  • Cohort 8

Part 2 Dose Expansion

  • Cohort A for subjects with HER2-positive advanced breast cancer
  • Cohort B for subjects with HER2-positive advanced gastric cancer/gastroesophageal junction cancer

Interventions

D3L-001

Intravenous administration

Primary outcome measure

  • Number of Participants With Adverse Events (AEs) [ Time Frame: Screening until Safety Follow Up visit (30 days after the last dose) ]
  • Maximum Tolerated Dose based on Dose-Limiting Toxicities (DLTs) [ Time Frame: At the end of Cycle 1 (each cycle is 21 days). ]

Central Contacts and Locations

Central contacts

Medical Director

+86 21 61635900D3bio_CT@d3bio.com

Locations

D3 Bio Investigative Site

Recruiting

New York, New York, United States, 10065

More Information

Sponsor

D3 Bio (Wuxi) Co., Ltd

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • HER-2 Positive
  • Advanced Solid Tumors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by D3 Bio (Wuxi) Co., Ltd on 2026-08-28.