A Multicenter, Single-Arm, Phase 2 Study to Evaluate the Safety, Efficacy and Pharmacokinetics of JK-1201I in Triple Negative Breast Cancer Patients with Brain Metastases
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 25
- 主要终点
- Progression-free Survival (PFS) according to RECIST 1.1 and RANO-BM
研究概览
简要总结
This study was designed to evaluate the safety, efficacy and pharmacokinetics of JK-1201I in triple negative breast cancer patients with brain metastases.
详细描述
This is a multicenter, single-arm, phase 2 study to evaluate the safety, efficacy and pharmacokinetics of JK-1201I in triple negative breast cancer patients with brain metastases.
Patients will receive JK-1201I until disease progression. The primary objective of this study is to assess whether treatment with JK-1201I prolongs progression-free Survival (PFS) according to RECIST 1.1 and RANO-BM in triple negative breast cancer patients with brain metastases.
The secondary objectives of the study are to further evaluate the efficacy, safety and pharmacokinetics of JK-1201I.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
JK-1201I
Participants will receive JK-1201I as an intravenous (IV) infusion at dose of 125mg/m2 on Day 1 of each 14-day cycle until a treatment discontinuation criterion is met as specified in the protocol.
干预措施: JK-1201I (Drug)
结局指标
主要结局
Progression-free Survival (PFS) according to RECIST 1.1 and RANO-BM
时间窗: Up to approximately 12 months.
Progression-free Survival (PFS) is defined as the time interval from the randomization to disease progression or death due to any cause.
次要结局
- Progression-free Survival (PFS) according to RECIST 1.1(Up to approximately 12 months.)
- Progression-free Survival (PFS) according to RANO-BM(Up to approximately 12 months.)
- Objective Response Rate (ORR) according to RECIST 1.1(Up to approximately 6 months.)
- Objective Response Rate (ORR) according to RANO-BM(Up to approximately 6 months.)
- Overall survival (OS)(Up to approximately 24 months.)
- Incidence and Grade of Participants with Adverse Events or Serious Adverse Events(Up to approximately 24 months.)
- Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for JK-1201I, Irinotecan, SN38 and SN38G(Up to 6 months.)
- Pharmacokinetic Parameter Maximum Concentration for JK-1201I, Irinotecan, SN38 and SN38G(Up to 6 months.)