Open Label Single Arm Phase Ib-II Study of Pre-operative IPH2201 in Patients With Locally Advanced Resectable Squamous Cell Carcinoma of the Oral Cavity
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 3
- 主要终点
- best objective response rate
研究概览
简要总结
The primary objective of this open label Phase Ib/II trial is to evaluate the clinical and pharmacological activity of IPH2201 as a single-agent in treatment-naïve pre-operative patients with operable Squamous Cell Carcinoma of the Oral Cavity .
43 patients are planned to be enrolled. The first 6 patients will receive IPH2201 at a dose of 4 mg/kg q2w x 4. Subsequent patients will be treated at a dose of 10 mg/kg q2w x 4. Standard loco-regional treatment with surgery followed by adjuvant therapy will be initiated after the last administration of IPH2201.
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
single arm
IPH2201 followed by standard surgery and standard postsurgical adjuvant therapy
干预措施: IPH2201 (Drug)
single arm
IPH2201 followed by standard surgery and standard postsurgical adjuvant therapy
干预措施: Standard Surgery (Procedure)
single arm
IPH2201 followed by standard surgery and standard postsurgical adjuvant therapy
干预措施: Postsurgical Adjuvant Therapy (Radiation)
结局指标
主要结局
best objective response rate
时间窗: 8 weeks
次要结局
未报告次要终点