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

Официальное название

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.

Обзор

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.

Вмешательства

• Биопрепарат D3L-001
  Intravenous administration

Первичные конечные точки

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

Вторичные конечные точки (10)

• D3L-001 minimum serum concentration (Ctrough) [Срок оценки: First dose up to 6 months]
• D3L-001 maximum observed plasma concentration (Cmax) [Срок оценки: First dose up to 6 months]
• D3L-001 time to maximum plasma concentration (tmax) [Срок оценки: First dose up to 6 months]
• D3L-001 half-life (t1/2) [Срок оценки: First dose up to 6 months]
• D3L-001 area under the concentration-time curve (AUC) [Срок оценки: First dose up to 6 months]
• Incidence of anti-drug antibodies (ADA) to D3L-001 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Until disease progression or end of treatment (up to approximately 6 months)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• D3 Bio Investigative Site — Stanford
• D3 Bio Investigative Site — Boston
• D3 Bio Investigative Site — New York
• D3 Bio Investigative Site — San Antonio

Китай · 3 центра

• D3 Bio Investigative Site — Харбин
• D3 Bio Investigative Site — Шанхай
• D3 Bio Investigative Site — Ханчжоу

Австралия · 2 центра

• D3 Bio Investigative Site — Sydney
• D3 Bio Investigative Site — Malvern

Идентификаторы

NCT: NCT05957536 · D3L-001-100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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