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在先进的固体瘤中,第一个类型瘤微环境调节器VT1021的第一个人体I期剂量升级试验

Devalingam Mahalingam¹, Wael Harb², Amita Patnaik³

¹Northwestern University Medical School, Chicago, IL, USA. Mahalingam@nm.org.

Communications medicine

|January 13, 2024

概括

VT1021是一种循环,在患有晚期固体瘤的患者中是安全且耐受良好的. 推的第2期剂量 (RP2D) 为11.8mg/kg,显示出临床益处,包括部分反应,支持其作为单剂治疗的潜力.

科学领域:

在瘤学瘤学.
免疫治疗是一种免疫疗法.
癌症治疗方法癌症治疗方法

背景情况:

VT1021是一种循环,通过诱导骨髓系衍生抑制细胞 (MDSC) 中的血栓蛋白-1 (TSP-1) 表达来调节瘤微环境 (TME).
TSP-1与CD36和CD47相互作用,促进瘤和内皮细胞亡以及TME内的免疫调节.

研究的目的:

确定在晚期固体瘤患者中推的VT1021第二阶段剂量 (RP2D).
评估VT1021.21的安全性,耐受性和药理动力学 (PK).

主要方法:

在研究VT1021-01 (NCT03364400) 中采用了修改后的3+3剂量升级设计.
患者在9个剂量队列 (0.5-15.6毫克/公斤) 中每周两次静脉注射VT1021.
使用CTCAE v5.0评估安全性,根据RECIST v1.1.1.评估抗瘤活性.

主要成果:

确定的RP2D为11.8mg/kg,没有观察到剂量限制性毒性 (0/38名患者).
与治疗相关的常见不良事件包括疲劳,恶心和输液反应 (全部为15.8%或以下).
观察到疾病控制率 (DCR) 为42.9%,其中12/28例患者显示出临床益处,其中包括一个胸腺瘤患者504天的部分反应.

结论:

在测试剂量中,VT1021表现出良好的安全性和耐受性.
11.8mg/kg的RP2D适合进一步的临床研究.
观察到的部分反应和稳定的疾病与瘤缩突出显示了VT1021作为单一疗法的潜力.

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