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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Objective response rate ( ORR )
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Objective response rate ( ORR )
时间窗: Approximately 2 years
Objective response rate (ORR) as assessed by investigators according to RECIST v.1.1
次要结局
- Disease Control Rate (DCR)(Approximately 2 years)
- Duration of Response (DOR)(Approximately 2 years)
- Progression Free Survival (PFS)(Approximately 2 years)
- Overall Survival (OS)(Approximately 2 years)
- Adverse events(Approximately 2 years)
- Area Under the Plasma Concentration Versus Time Curve (AUC) of DAT-2645(Approximately 2 years)
- Time to Achieve Maximal Plasma Concentration (Tmax) of DAT-2645(Approximately 2 years)
- Maximal Plasma Concentration (Cmax) of DAT-2645(Approximately 2 years)