晚期固体瘤患者的E7386:一期I期研究的剂量升级部分和扩展部分的结果
S Kondo1, N Yamamoto1, Y Katsuya1
1Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.
ESMO open
|December 12, 2025
概括
作为CBP/β-catenin相互作用的抑制剂,E7386在患有高级固体瘤的患者中显示出可管理的安全性. 在患有小肠癌和desmoid瘤的患者中观察到部分反应.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
背景情况:
- E7386是一种口服活性抑制剂,向CBP/β-catenin相互作用.
- 这一第一阶段研究 (研究103) 研究了E7386在患有晚期,不可切除或复发 (A/U/R) 固体瘤的患者中.
研究的目的:
- 评估E7386在患有晚期固体瘤的患者中的安全性和耐受性.
- 评估E7386.6的药理动力学 (PK) 和抗瘤活性.
主要方法:
- 在日本进行的一项开放标签,剂量升级和扩展研究.
- 患有A/U/R固体瘤的患者接受了E7386;剂量限制性毒性决定了每天两次120毫克的推剂量 (b.i.d. ) 的情况.
- 评估了安全性,耐受性,药理学和疗效 (RECIST v1.1).这些问题都得到了评估.
主要成果:
- 招募了55名患者;结直肠癌是最常见的瘤类型.
- 大多数患者经历了治疗出现的不良事件 (TEAE),主要是恶心和吐,这些通常是轻微的和可控的.
- 在剂量升级阶段观察到两种部分反应 (PR):一种在小肠癌中,一种在瘤中.
结论:
- 在重度预治疗的患者中,E7386显示出可管理的安全性和剂量依赖的PK特征.
- 在特定的瘤类型中观察到部分反应,这表明在某些患者群体中具有潜在的疗效.
关键词:
E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7386 E7剂量升级剂量的升级.剂量扩大剂量扩大剂量第一个阶段I阶段.在安全方面,安全是安全的.固体瘤是一个固体瘤.更多相关视频
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