开放标签,多中心,I期研究,评估在患有高级固体瘤的患者中对Adavosertib Plus Durvalumab的安全性和耐受性
Manish R Patel1,2, Gerald S Falchook3, Judy S Wang4,5
1Florida Cancer Specialists, 600 N Cattlemen Rd, Suite #200, Sarasota, FL, 34232, USA. mpatel@flcancer.com.
Targeted oncology
|November 19, 2024
概括
这项研究确定了在耐火性固体瘤患者中,阿达沃谢蒂布加杜尔瓦卢马布的最大耐受剂量 (MTD) 和推的II期剂量 (RP2D). 这种组合显示出可管理的安全性概况,初步证据表明它具有抗瘤活性.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 阿达沃谢蒂布 (AZD1775) 是一种小分子Wee1抑制剂.
- 杜尔瓦卢马布是一种PD-L1抑制剂.
- 对耐火固体瘤进行研究的组合疗法.
研究的目的:
- 评估阿达沃谢蒂布加杜尔瓦卢马布的安全性,耐受性,药理动力学和初步抗瘤活性.
- 定义最大耐受剂量 (MTD) 和推的II期剂量 (RP2D).
主要方法:
- 第1阶段,非随机的开放标签研究.
- 剂量升级队列用于确定MTD/RP2D.
- 包括组织学证实瘤不耐标准治疗的患者.
主要成果:
- 55名患者接受了阿达沃谢蒂布和杜尔瓦卢马布.
- 每天两次服用阿达沃谢蒂布的MTD为150毫克两次;RP2D是150毫克两次与杜尔瓦卢马布1500毫克Q4W.
- 每天服用一次阿达沃谢蒂布的MTD为300毫克qd与杜尔瓦卢马布1500毫克Q4W.
结论:
- 在先进的固体瘤中,定义了Adavosertib加Durvalumab的MTD/RP2D.
- 安全概况与个别药剂相一致.
- 观察到有限的抗瘤活性的初步证据.
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