一项1a/1b期首次在人体上进行的研究 (COMPASSION-01) 评估了cadonilimab在患有晚期固体瘤的患者身上
Sophia Frentzas1, Hui K Gan2, Rasha Cosman3
1Department of Medical Oncology, Monash Health, Melbourne, Australia; Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.
Cell reports. Medicine
|October 18, 2023
概括
在一期临床试验中,针对PD-1和CTLA-4的双特异性抗体cadonilimab在患有晚期固体瘤的患者中表现出良好的耐受性和有前途的疗效.
科学领域:
- 免疫治疗是一种免疫疗法.
- 在瘤学瘤学.
- 临床药理学 临床药理学
背景情况:
- 与双特异性抗体同时抑制PD-1和CTLA-4提供了与单剂疗法相比增强抗瘤疗效的潜在策略.
- 双特异性抗体可以针对多个免疫检查点,可能导致协同效应和更好的安全性.
研究的目的:
- 为了评估cadonilimab的安全性,耐受性和初步疗效,cadonilimab是一种针对PD-1和CTLA-4的新型双特异抗体.
- 为了确定cadonilimab在晚期固体瘤患者的未来临床研究的推剂量.
主要方法:
- 一个第一阶段临床试验,涉及剂量升级 (n=39) 和剂量扩展 (n=80) 队列.
- 安全性评估,包括剂量限制性毒性和与治疗相关的不良事件.
- 通过总体反应率和反应持续时间来评估疗效.
主要成果:
- 没有达到最大耐受剂量;每两周6毫克/公斤被确定为推剂量.
- 与输液相关的反应是最常见的不良事件 (18.5%),主要是1/2.2级.
- 总体响应率为13.4%,响应的平均持续时间为12.9个月. 与免疫相关的不良事件发生在44.5% (任何等级) 和6.7% (等级≥3) 的患者中.
结论:
- 卡多尼利马布在患有晚期固体瘤的患者中耐受性良好.
- 双特异性抗体显示出有前途的抗瘤活性,支持在临床试验中进一步调查.
- 与cadonilimab同时抑制PD-1和CTLA-4代表了癌症免疫疗法的潜在治疗进步.
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