第1阶段剂量扩大和生物标志物研究评估了先进的瘤微环境调节器VT1021在患有高级固体瘤的患者中
Jian Jenny Chen1, Melanie Y Vincent2, Dale Shepard3
1Vigeo Therapeutics, Cambridge, MA, USA. jenny.chen@vigeotx.com.
Communications medicine
|May 21, 2024
概括
VT1021是固体瘤的安全和耐受性良好的治疗剂,在复发性质母细胞瘤中表现出有前途的活性. 生物标志物分析确定了未来临床研究的潜在指标.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 瘤微环境 瘤微环境
背景情况:
- 一种新型治疗药物VT1021刺激血栓蛋白-1 (TSP-1),以抑制瘤生长并重塑瘤微环境.
- 报告了从实体瘤的第一阶段研究中获得的先前剂量升级数据.
- 本研究介绍了同一试验剂量扩大阶段的研究结果.
研究的目的:
- 评估VT1021的安全性,耐受性,临床反应和生物标志物概况,在I期研究的剂量扩展阶段.
- 为了确认治疗剂在患有固体瘤的患者中的疗效.
主要方法:
- 通过与治疗相关的不良事件评估的安全性和耐受性.
- 使用RECIST v1.1和iRECIST标准评估的临床反应.
- 使用多重离子束成像和ELISA进行的生物标记分析.
主要成果:
- VT1021表现出良好的安全性,大多数是1-2级不良事件,没有4级或5级事件.
- 在复发性质母细胞瘤 (rGBM) 患者中 (n=22),VT1021显示了45%的疾病控制率 (DCR).
- 确认TSP-1诱导和瘤微环境重塑;确定了潜在的血细胞因子生物标志物.
结论:
- 在患有固体瘤的患者中,VT1021是安全的,耐受性良好.
- 该药物已显示出有前途的临床活性,并已进入质母细胞瘤II/III期研究.
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