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在先前治疗局部晚期或转移性固体瘤时,tebotelimab加上niraparib:一期1b剂量升级和扩展研究

Miao-Zhen Qiu¹, Hongming Pan², Ka On Lam³

¹Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.

|May 30, 2025

概括

与niraparib结合的tebotelimab在患有晚期胃癌,三阴性乳腺癌,胆道癌和子宫内膜癌的患者中显示出可管理的安全性. 在这项1b期研究中,组合疗法显示出有限的抗瘤活性.

科学领域:

在瘤学瘤学.
免疫治疗是一种免疫疗法.
药理学药理学是指药理学的学科.

背景情况:

第1b期研究调查了tebotelimab (PD-1 x LAG-3双特异抗体) 以及niraparib (PARP抑制剂).
专注于安全性,耐受性和晚期固体瘤中的抗瘤活性.
包括胃癌,三阴性乳腺癌 (TNBC),胆道癌 (BTC) 和子宫内膜癌患者.

研究的目的:

确定推的第2阶段剂量 (RP2D) 的tebotelimab与niraparib结合.
评估这种联合治疗的安全性和耐受性.
评估特定癌症类型的初步抗瘤活性.

主要方法:

开放标签,单臂,剂量升级和扩展研究.
德博特利马布是静脉注射的;尼拉帕里布是每天口服的.
之前接受过治疗的晚期癌症患者被纳入.

主要成果:

对于tebotelimab的RP2D确定为600mgQ2W,没有剂量限制性毒性.
在65.0%的患者中发生3级以上的治疗引起的不良事件 (TEAE);严重的TEAE发生在41.7%的患者中.
总体应答率因癌症类型而异,观察到的活性有限.

结论:

德博特利马布加尼拉帕里布具有可容忍和可管理的安全性.
组合疗法在先前治疗的固体瘤中显示出有限的抗瘤活性.
进一步调查可能是有必要的.

关键词:

尼拉帕里布里布里布.第一个阶段1bb.固体瘤是一种固体瘤.在这里,你只能说"tebotelimab".

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