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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-19

Study Completion Date

2026-03-11

Brief Summary

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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.

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Detailed Description

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Conditions

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HER-2 Positive Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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

Group Type EXPERIMENTAL

D3L-001

Intervention Type BIOLOGICAL

Intravenous administration

Interventions

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D3L-001

Intravenous administration

Intervention Type BIOLOGICAL

Eligibility Criteria

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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 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No