在患有高级固体瘤的患者中,对TTI-101进行I期试验,这是STAT3的第一类口服抑制剂
Apostolia M Tsimberidou1, David J Vining2, Sukeshi P Arora3
1Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
概括
新型药物TTI-101是一种信号传感器和转录3抑制剂的激活剂,在晚期转移性癌症患者中表现出有前途的抗瘤活性. 这种耐受性良好的疗法在各种瘤类型中显示出已确认的部分反应.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 分子生物学分子生物学
背景情况:
- 信号转换器和转录3激活器 (STAT3) 对癌细胞存活和免疫规避至关重要.
- 向STAT3为晚期转移性癌症提供了一个潜在的治疗策略.
研究的目的:
- 在I期临床试验中评估选择性STAT3抑制剂TTI-101的安全性和耐受性.
- 确定TTI-101推的II期剂量,用于晚期转移性癌症患者.
主要方法:
- 一个第一阶段,第一阶段.
- 3+3 3+3 是一个3+3的组合.
- 在64名晚期转移性癌症患者中,对口服TTI-101进行了剂量升级研究.
- 在28天周期内,在四个剂量级 (3.2至25.6毫克/公斤/天) 中使用了三种TTI-101配方.
主要成果:
- TTI-101耐受性良好,没有观察到剂量限制性毒性或致命的治疗相关不良事件.
- 确定推的II期剂量为12.8mg/kg/天 (DL3),在此剂量之前观察到线性药理动力学.
- 在41名可评估患者中,12%的患者实现了确认的部分反应 (cPR),其中包括3名肝细胞癌患者,41%的患者有稳定的疾病.
结论:
- TTI-101在患有晚期转移性固体瘤的患者中显示出良好的安全性和有前途的抗瘤活性,作为单一治疗.
- 在不同类型的瘤中观察到确认的部分反应,需要进一步调查.
- 目前正在进行TTI-101在肝细胞癌中的II期研究.
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