NCT07370818尚未招募2 期
An Open-label, Dose-finding and Randomized Active-controlled, Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of JPI-547 With Bevacizumab Maintenance Therapy in Relapsed Ovarian Cancer Patients Previously Treated With PARP Inhibitor Maintenance Therapy and Responding to Last Platinum Chemotherapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Part A: Maximum tolerated dose (MTD) and recommended dose (RD)(RP2D)
研究概览
简要总结
This study aims to to evaluate the efficacy, safety, and pharmacokinetics of JPI- 547 with bevacizumab maintenance therapy in relapsed ovarian cancer patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer [High-grade serous carcinoma (HGSC), Grade 2/3 endometrioid carcinoma]
- •Patients whose BRCA 1/2 gene mutation status and/or Homologous Recombination Deficiency (HRD) status.
- •Patients who received platinum-based chemotherapy followed by PARP inhibitor maintenance therapy,
- •Patients who had received chemotherapy before participating in the clinical trial and responded to platinum-based chemotherapy.
- •Those with Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Individuals with confirmed adequate hematological, renal, and hepatic function (laboratory tests may be repeated once during the screening period)
排除标准
- •Patients with a history of severe drug hypersensitivity or hypersensitivity to the investigational drug, its components, or drugs within the same class.
- •Individuals with dysphagia
- •Patients with a confirmed specific medical history or a past surgical history.
- •Patients with specific comorbidities or medical abnormalities.
- •Pregnant women, lactating women, or women of childbearing potential who do not agree to use appropriate contraception during the clinical trial period and for 24 weeks after administration of the investigational medicinal product.
- •Those who have administered other investigational products or have received investigational medical device procedures within 4 weeks of the baseline
- •Other patients who are inappropriate or unable to participate in this clinical study at the discretion of the investigator.
研究组 & 干预措施
Bevacizumab
Experimental
干预措施: Bevacizumab (Drug)
JPI-547+Bevacizumab
Experimental
干预措施: JPI-547 (Drug)
JPI-547+Bevacizumab
Experimental
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Part A: Maximum tolerated dose (MTD) and recommended dose (RD)(RP2D)
时间窗: The dose-limiting toxicity evaluation window is 21 days
Part B: Progression free survival(PFS)
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 74 months.
次要结局
未报告次要终点
研究者
研究点 (1)
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