NCT04492293招募中2 期
A Phase 2, Multicenter, Single Arm, Open-lable Study of ICP-192 in Subjects With Surgically Unresectable or Metastatic Bladder Urothelial Cancer With FGFR Genetic Aberrations.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 115
- 试验地点
- 22
- 主要终点
- ORR
研究概览
简要总结
This is a phase 2, multicenter, single arm, open-lable study of ICP-192. The purpose of this study is to evaluate efficacy of ICP-192 in subjects with surgically unresectable or metastatic bladder urothelial cancer.
详细描述
bladder urothelial cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Prior treatment with selective FGFR inhibitors or FGFR antibodies.
- •Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity.
研究组 & 干预措施
ICP-192
Experimental
ICP-192
干预措施: ICP-192 (Drug)
结局指标
主要结局
ORR
时间窗: From the time of first dose until objective disease progression, an average of 6 months
Objective Response Rate
次要结局
- PFS(From the time of first dose until objective disease progression, an average of 6 months)
- DCR(From the time of first dose until objective disease progression, an average of 6 months)
- DOR(From the time of first dose until objective disease progression, an average of 6 months)
- OS(From the time of first dose until objective disease progression, an average of 1 months)
研究者
研究点 (22)
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