一个第1阶段的CD40激动剂MEDI5083与杜尔瓦卢马布结合在患有晚期固体瘤的患者中进行的研究
Ben Tran1, Mark Voskoboynik2,3, Johanna Bendell4
1Peter MacCallum Cancer Centre, Melbourne, 8006, Australia.
Immunotherapy
|September 12, 2024
概括
与杜尔瓦卢马布 (durvalumab) 结合的第一个CD40agonistMEDI5083的人类试验显示了显著的注射部位反应和毒性,限制了MEDI5083在先进的固体瘤中的进一步发展.
科学领域:
- 免疫治疗是一种免疫疗法.
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- CD40激动剂是一种有前途的免疫疗法药物.
- 杜尔瓦卢马布是一种成熟的免疫检查点抑制剂.
- 结合免疫疗法可能会增强抗瘤反应.
研究的目的:
- 评估MEDI5083的安全性和有效性,一种CD40激动剂,与杜尔瓦卢马布结合使用.
- 评估MEDI5083在患有晚期固体瘤的患者中的安全性.
- 确定MEDI5083.3的最大耐受剂量 (MTD).
主要方法:
- 首次在人类身上进行开放性研究.
- 患者接受了MEDI5083 (3-7.5 mg SC Q2W×4剂) 和杜尔瓦卢马布 (1500 mg Q4W) 连续或同时.
- 主要终点:安全性;次要终点:疗效.
主要成果:
- 三十八名患者接受治疗;9人有3级以上的不良事件 (AE).
- 最常见的副作用:注射部位反应 (ISR),疲劳,恶心,食欲下降.
- MEDI5083的MTD是5毫克;ISR是一个剂量限制性毒性. 目标响应率为2.8%.
结论:
- 梅迪5083的毒性概况,特别是ISR,限制了其进一步的临床开发.
- 组合疗法在这个患者群体中显示出有限的疗效.
- 不建议对目前的MEDI5083进行进一步的研究.
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