A Study of DAT-2645 in Patients With BRCA1/2 Mutations or HRD-Positive Ovarian Cancer

Официальное название

A Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of DAT-2645 in Patients With BRCA1/2 Deleterious Mutations or HRD-Positive Advanced/Metastatic Ovarian Cancer

Обзор

This is a Phase II, multicenter, single-arm dose expansion trial planned to enroll up to 30 subjects with advanced or metastatic ovarian cancer. The Objective is to conduct a preliminary evaluation of the efficacy, the safety, tolerability and PK profile of DAT-2645

Подробное описание

This study is a multicenter, dose expansion, single-arm Phase II clinical trial. Administered once daily in the morning on an empty stomach at the recommended dose (RDE). Each treatment cycle consists of 21 days, with continuous administration until the first occurrence of disease progression, intolerable toxicity, withdrawal from the study, loss to follow-up, or initiation of new anticancer therapy. The trial plans to enroll 30 participants with advanced or metastatic ovarian cancer. The sponsor or investigator may terminate patient enrollment early based on interim efficacy and safety data.

Вмешательства

• Препарат DAT-2645 tablet
  Oral administration with 21 days each cycle

Первичные конечные точки

• Objective response rate ( ORR ) [Срок оценки: Approximately 2 years]

Вторичные конечные точки (8)

• Disease Control Rate (DCR) [Срок оценки: Approximately 2 years]
• Duration of Response (DOR) [Срок оценки: Approximately 2 years]
• Progression Free Survival (PFS) [Срок оценки: Approximately 2 years]
• Overall Survival (OS) [Срок оценки: Approximately 2 years]
• Adverse events [Срок оценки: Approximately 2 years]
• Area Under the Plasma Concentration Versus Time Curve (AUC) of DAT-2645 [Срок оценки: Approximately 2 years]
• Time to Achieve Maximal Plasma Concentration (Tmax) of DAT-2645 [Срок оценки: Approximately 2 years]
• Maximal Plasma Concentration (Cmax) of DAT-2645 [Срок оценки: Approximately 2 years]

Критерии участия

Критерии включения

• sign a written informed consent form
• At least 18 years of age (inclusive)
• Epithelial ovarian cancer confirmed by histopathology or cytopathology
• BRCA1/2 mutation or HRD-positive status
• Patients who have failed standard treatment or are unable to tolerate standard treatment
• Patients must have received no more than five prior treatment lines
• At least one measurable lesion
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• Bone marrow reserve and organ function must meet the requirements
• Negative result on a blood pregnancy test for a woman of childbearing age

Критерии исключения

• Received small-molecule chemotherapy or targeted therapy within 2 weeks or 5 half-lives prior to the first dose
• Received treatment with an anticancer biological therapy within 4 weeks prior to the first dose
• Underwent major surgery within 4 weeks prior to the first dose
• Has previously received treatment with a PARG inhibitor
• Inadequate response to previous PARP inhibitor maintenance therapy
• With central nervous system metastases
• Patients with clinically significant cardiovascular or cerebrovascular diseases
• Uncontrolled active infections requiring intravenous antibiotics or hospitalization
• Adverse reactions from prior anticancer therapy have not yet resolved to a grade ≤1

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

Китай · 2 центра

• Research site — Гуанчжоу
• Research site — Пекин

Идентификаторы

NCT: NCT07652073 · DAT2645-Clin-201-CN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗