特拉贝克丁素加上针对CD13的组织因子tTF-NGR,用于治疗复发性或耐火性软组织肉瘤:转化数据,临床安全性和疗效
Kathrin Hessling1, Caroline Brand1, Christian Schwöppe1
1Department of Medicine A, Hematology, Oncology and Pneumology, University Hospital of Muenster, Albert‑Schweitzer‑Campus 1, 48149, Muenster, Germany.
Scientific reports
|February 19, 2026
概括
在TRABTRAP试验中,用于软组织肉瘤,结合了trabectedin和tTF-NGR. 推的起始剂量表现出良好的耐受性,支持进一步的随机研究.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 翻译医学是一种翻译医学.
背景情况:
- 特拉贝克丁是复发性/耐火性软组织肉瘤的标准治疗方法.
- 瘤向融合NGR (tTF-NGR) 向瘤血管,导致闭塞和心脏病发作.
- 连续使用可能会通过将它困在瘤中来增强特拉贝克丁的疗效.
研究的目的:
- 评估将特拉贝克丁与tTF-NGR结合的安全性和耐受性.
- 为了确定TRABTRAP试验的最大耐受剂量 (MTD) 和建议的起始剂量.
- 总结TRABTRAP试验最初患者队列的翻译数据和安全性调查结果.
主要方法:
- 在TRABTRAP试验的第一阶段安全运行队列中.
- 特拉贝克丁和tTF-NGR的组合疗法连续使用.
- 对tTF-NGR的剂量升级,以确定剂量限制性毒性 (DLT).
主要成果:
- 一种1.5mg/m2的trabectedin和0.5mg/m2的tTF-NGR的组合剂量被确定为推的起始剂量.
- 在接受推起始剂量的患者中,没有观察到剂量限制性毒性 (DLT).
- 较高剂量或tTF-NGR的延长应用导致3级DLT,包括心肌梗塞和血栓塞栓事件.
结论:
- 在推剂量下,trabectedin和tTF-NGR的组合是可行的和可以容忍的.
- 确定的MTD和推的起始剂量支持正在进行的TRABTRAP试验的随机部分.
- 翻译和临床数据支持继续研究这种用于软组织肉瘤的联合治疗方法.
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