A Study of DAT-2645 in Patients With BRCA1/2 Mutations or HRD-Positive Ovarian Cancer
2026年6月21日 更新者：Danatlas Pharmaceuticals Co., Ltd
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
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
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
30
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Clinical Operation Director
- 电话号码：+86-10-67803200
- 邮箱：information@danatlas.com
研究联系人备份
- 姓名：Regulatory Affairs Manager
- 电话号码：+86-13717825107
- 邮箱：Huixian.chen@danatlas.com
学习地点
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Beijing、中国、100021
- Research Site
-
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Guangdong
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Guangzhou、Guangdong、中国、510050
- Research Site
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：DAT-2645 tablet
Monotherapy under the recommended dose (RDE)
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Oral administration with 21 days each cycle
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Objective response rate ( ORR )
大体时间：Approximately 2 years
|
Objective response rate (ORR) as assessed by investigators according to RECIST v.1.1
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Approximately 2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Disease Control Rate (DCR)
大体时间：Approximately 2 years
|
Defined as not meeting the criteria for progression and PR(partial response)
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Approximately 2 years
|
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Duration of Response (DOR)
大体时间：Approximately 2 years
|
DOR(duration of response) per RECIST v1.1(Response Evaluation Criteria in Solid Tumors).
Measured in CT/MRI image from the time when measurement criteria for complete/ partial response are met till time when progression of the disease is documented.
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Approximately 2 years
|
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Progression Free Survival (PFS)
大体时间：Approximately 2 years
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Progression- free survival (PFS) by RECIST V1.1 criteria- from the beginning of treatment to the progression of disease or death.
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Approximately 2 years
|
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Overall Survival (OS)
大体时间：Approximately 2 years
|
Overall Survival (OS) was defined as the time interval between a patient randomized and death from any cause or the end of the last follow-up date.
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Approximately 2 years
|
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Adverse events
大体时间：Approximately 2 years
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The incidence of TEAE, TRAE, SAE, and clinically significant abnormalities (including laboratory tests, vital signs, physical examination, and electrocardiogram).
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Approximately 2 years
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Area Under the Plasma Concentration Versus Time Curve (AUC) of DAT-2645
大体时间：Approximately 2 years
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PK parameter: AUC of DAT-2645
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Approximately 2 years
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Time to Achieve Maximal Plasma Concentration (Tmax) of DAT-2645
大体时间：Approximately 2 years
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PK parameter: Tmax of DAT-2645
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Approximately 2 years
|
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Maximal Plasma Concentration (Cmax) of DAT-2645
大体时间：Approximately 2 years
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PK parameter: Cmax of DAT-2645
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Approximately 2 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月15日
初级完成 (估计的)
2027年11月30日
研究完成 (估计的)
2028年3月30日
研究注册日期
首次提交
2026年6月11日
首先提交符合 QC 标准的
2026年6月11日
首次发布 (实际的)
2026年6月16日
研究记录更新
最后更新发布 (实际的)
2026年6月25日
上次提交的符合 QC 标准的更新
2026年6月21日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.