RECRUITING

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

Conditions

HER-2 Positive Advanced Solid Tumors HER-2 Positive Advanced Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Quick Facts

Study Start:2023-09-19

Study Completion:2026-03-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05957536

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* Subject has any prior treatment with anti-CD47 or SIRPα agent. * Subject has major surgery or radiotherapy, immunostimulatory agents, investigational agents, or any other anticancer treatment including chemotherapy, targeted therapy, biologics that is not completed 28 days before first dose of study medication. * 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.

Inclusion Criteria

Exclusion 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.

* Subject has any prior treatment with anti-CD47 or SIRPα agent.
* Subject has major surgery or radiotherapy, immunostimulatory agents, investigational agents, or any other anticancer treatment including chemotherapy, targeted therapy, biologics that is not completed 28 days before first dose of study medication.
* 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.

Contacts and Locations

Study Contact

Medical Director

CONTACT

+86 21 61635900

D3bio_CT@d3bio.com

Study Locations (Sites)

D3 Bio Investigative Site

Stanford, California, 94305

United States

D3 Bio Investigative Site

Boston, Massachusetts, 02215

United States

D3 Bio Investigative Site

New York, New York, 10065

United States

D3 Bio Investigative Site

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: D3 Bio (Wuxi) Co., Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-19

Study Completion Date2026-03-11

Study Record Updates

Study Start Date2023-09-19

Study Completion Date2026-03-11

Terms related to this study

Keywords Provided by Researchers

HER-2 Positive
Advanced Solid Tumors

Additional Relevant MeSH Terms

HER-2 Positive Advanced Solid Tumors