在患有晚期或转移性固体瘤的患者中,对ASP9801瘤病毒进行第一阶段的开放性研究
John L Villano1, Jason J Luke2, Ricklie Julian3
1Departments of Medicine, Neurosurgery, and Neurology, University of Kentucky College of Medicine, Lexington, Kentucky, USA jlvillano@uky.edu.
Journal for immunotherapy of cancer
|February 11, 2026
概括
ASP9801,一种瘤性病毒疗法,在先进的固体瘤中显示出可接受的安全性. 由于剂量扩大阶段的疗效不足,该研究被停止了.
科学领域:
- 在瘤学瘤学.
- 病毒学 病毒学
- 免疫治疗是一种免疫疗法.
背景情况:
- 瘤病毒被设计成可以选择性地感染和杀死癌细胞,刺激抗瘤免疫反应.
- ASP9801是一种致癌病毒,旨在表达抗白素-7和抗白素-12,这些细胞因子调节免疫系统.
研究的目的:
- 评估ASP9801的安全性,耐受性,药理动力学和初步抗瘤活性,用于患有晚期固体瘤的患者.
- 为了确定ASP9801.1.的最大耐受剂量 (MTD) 和推的第二阶段剂量 (RP2D).
主要方法:
- 一个第一阶段的剂量升级研究,有两个部分:单疗剂量升级和剂量扩展.
- 第1部分涉及ASP9801单疗法,而第2部分涉及ASP9801单疗法或与pembrolizumab结合.
- 患者在皮肤/皮下或内脏病变中接受了ASP9801的瘤内注射.
主要成果:
- 建议的ASP9801第二阶段剂量 (RP2D) 确定为5×10^8形成斑块的单位/毫升.
- 与治疗相关的不良事件包括发烧,恶心,疲劳和,通常是可以控制的.
- 在接受ASP9801与pembrolizumab联合治疗的患者中观察到一个部分反应,客观反应率为9.1%.
结论:
- 单独或与pembrolizumab一起使用的ASP9801显示出一般耐受性良好的安全性.
- 该研究在剂量扩大阶段中断,原因是缺乏证明的疗效.
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