ONO-4538 Multicenter, Open-label, Uncontrolled, Phase I Multiple Dose Study in Solid Tumor
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 5
- 主要终点
- Efficacy outcome: Response rate
研究概览
简要总结
The objective of this study is to investigate the safety, pharmacokinetics, pharmacology and efficacy of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The treatment phase has been completed in the ONO-4538-13 study
排除标准
- •The development of PD is identified by the principal or sub investigator according to the RECIST guideline (version 1.1) only in case in which the unplanned tumor assessment with diagnostic image is performed in the treatment phase of ONO-4538-13 study.
- •It is determined that continuing the treatment is not appropriate because the worsening of clinical symptoms attributed to disease progression occurs.
研究组 & 干预措施
ONO-4538 1mg/kg
ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, 3 times once every 2 weeks in each 6-week cycle
干预措施: ONO-4538 (Drug)
ONO-4538 3mg/kg
ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, 3 times once every 2 weeks in each 6-week cycle
干预措施: ONO-4538 (Drug)
ONO-4538 10mg/kg
ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, 3 times once every 2 weeks in each 6-week cycle
干预措施: ONO-4538 (Drug)
结局指标
主要结局
Efficacy outcome: Response rate
时间窗: Approximately 6 months
Efficacy outcome: Progression free survival
时间窗: Approximately 6 months
Safety outcome: The number of subjects with overall adverse events
时间窗: Approximately 6 months
PK outcome: Cmax of ONO-4538
时间窗: Approximately 10 months
Safety outcome: The number of deaths
时间窗: Approximately 6 months
次要结局
未报告次要终点