在复发/耐药的先进固体瘤患者中,对ANV419进行了第一阶段的第一次人体剂量升级研究
Markus Joerger1, Emiliano Calvo2, Heinz Laubli3
1Department of Medical Oncology & Hematology, Cantonal Hospital, St. Gallen, Switzerland markus.joerger@kssg.ch.
Journal for immunotherapy of cancer
|January 20, 2024
概括
ANV419是一种抗体-细胞因子融合,在先进的固体瘤中表现出良好的耐受性和抗瘤活性. 在第一阶段试验中,推的第二阶段剂量为243μg/kg.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 药理学 药理学是指药理学的学科.
背景情况:
- ANV419 是一种抗体-细胞因子融合蛋白,它结合了互白素-2 (IL-2) 与抗IL-2抗体.
- 它选择性地准IL-2受体βγ子单元,刺激杀伤瘤的CD8+T细胞和NK细胞,同时节省调控性T细胞.
研究的目的:
- 评估ANV419的安全性,耐受性,并确定最大耐受剂量 (MTD) 和推的第二阶段剂量 (RP2D).
- 描述晚期固体瘤患者的药理动力学,药理动力学和瘤反应.
主要方法:
- 一个开放的,多中心的第一阶段研究 (NCT04855929) 招募了高级固体瘤的成年患者.
- ANV419每两周一次静脉注射,剂量升级以确定MTD和RP2D.
- 报告了40名患者的临时结果.
主要成果:
- MTD和RP2D被确定为243μg/kg.
- 常见的不良事件包括发烧,寒和细胞因子释放综合征;淋巴缺血是暂时的.
- 在243μg/kg时,64%的患者实现了稳定疾病或更好,其中包括一个确认的部分反应.
结论:
- 高达243μg/kg的ANV419在严重预治疗的患有晚期固体瘤的患者中耐受良好.
- 该药物显示了抗瘤活性的初步迹象.
- MTD/RP2D是为了未来的临床开发而建立的.
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