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RecruitingInterventionalPhase 1

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.

NCT ID: NCT05957536Sponsor: D3 Bio (Wuxi) Co., LtdLast updated: 2026-03-13

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.

Arms & interventions

  • BiologicalD3L-001

    Intravenous administration

Outcome measures

Primary

  • 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).

Secondary

  • D3L-001 minimum serum concentration (Ctrough)

    Time frame: First dose up to 6 months

  • D3L-001 maximum observed plasma concentration (Cmax)

    Time frame: First dose up to 6 months

  • D3L-001 time to maximum plasma concentration (tmax)

    Time frame: First dose up to 6 months

  • D3L-001 half-life (t1/2)

    Time frame: First dose up to 6 months

  • D3L-001 area under the concentration-time curve (AUC)

    Time frame: First dose up to 6 months

  • Incidence of anti-drug antibodies (ADA) to D3L-001

    Time frame: First dose up to 6 months

  • Objective response rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

    Time frame: Until disease progression or end of treatment (up to approximately 6 months)

  • Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

    Time frame: Until disease progression or end of treatment (up to approximately 6 months)

  • Disease control rate (DCR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1

    Time frame: Until disease progression or end of treatment (up to approximately 6 months)

  • Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

    Time frame: Until disease progression or end of treatment (up to approximately 6 months)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (4)

D3 Bio Investigative Site

Stanford, California, 94305

Recruiting

D3 Bio Investigative Site

Boston, Massachusetts, 02215

Recruiting

D3 Bio Investigative Site

New York, New York, 10065

Recruiting

D3 Bio Investigative Site

San Antonio, Texas, 78229

Terminated