A Phase 2, Open-Label, Multi-Center Study to Evaluate Efficacy, Safety and Tolerability of KN046 in Subjects With Thymic Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This is a Phase 2, open-label, multi-center, single arm study in subjects with advanced thymic carcinoma after failure of platinum-based combination chemotherapy. Subjects should have documented progressive disease while on platinum-based combination chemotherapy. If subjects discontinued platinum-based therapy due to reasons other than progressive disease, subjects should have completed at least 2 cycles of platinum-based combination chemotherapy before the commencement of documented progressive disease. Subjects will be treated with KN046 5 milligram per kilogram every 2 weeks.
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
- 未提供
研究组 & 干预措施
Thymic carcinoma
enrolled subjects will receive KN046 every 2 weeks.
干预措施: KN046 (Drug)
结局指标
主要结局
ORR
时间窗: up to 2 years
ORR (best overall response) per RECIST v1.1 calculated as the proportion of subjects with a best overall response defined as confirmed complete response or confirmed partial response (CR+PR) by Independent Review Committee;
次要结局
- DOR(up to 3 years)
- DCR(up to 3 years)
- CBR(up to 3 years)
- PFS(up to 3 years)
- TTR(up to 3 years)