NCT02053220已完成1 期
A Phase 1 Clinical Study of Intra-tumoural Injection or Intravenous Infusion of a Group B Oncolytic Adenovirus (ColoAd1) in Patients With Cancer Who Are Candidates for Resection of Primary Tumour
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Akamis Bio
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Composite measure of viral delivery and spread
研究概览
简要总结
To assess the pattern of ColoAd1 viral delivery and viral expression within colon tumour tissue when administered by intra-tumoural injection or within colon, non-small cell lung, bladder and renal cell tumour tissues following ColoAd1 administration by intravenous infusion.
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
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Composite measure of viral delivery and spread
时间窗: Up to Day 25
To assess the pattern of viral delivery and viral spread of ColoAd1 within tumour tissue when administered either by intra-tumoural injection or by intravenous infusion. Viral delivery and spread will be measured by immunohistochemical staining for ColoAd1 in tumour sections taken from patients. Presence of virus will also be detected by qPCR analysis of tumour tissue.
次要结局
未报告次要终点
研究者
研究点 (2)
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