在患有转移性固体瘤的参与者中对Zilovertamab Vedotin进行第二阶段研究
Funda Meric-Bernstam1, Martin Gutierrez2, Enrique Sanz-Garcia3
1The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
Cancer research communications
|August 5, 2025
概括
齐洛韦他马布维多丁在转移性实体瘤患者中显示出极少的抗瘤活性,只观察到一个部分反应. 抗体-药物结合物证明了可控的安全性,疲劳和恶心是常见的副作用.
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:
- 齐洛韦他马布维多丁是一种抗体-药物结合体,向受体类型的孤儿受体1 (ROR1) 类型的氨酸激酶受体.
- 以前的研究表明,在复发性或耐火性非霍奇金淋巴瘤中,可控的安全性和有前途的抗瘤活性.
研究的目的:
- 评估先前治疗过转移性固体瘤的患者的齐洛韦塔马布维多丁的安全性和疗效.
- 评估客观反应率 (ORR) 并将ROR1蛋白表达与临床结果相关联.
主要方法:
- 第二阶段,开放标签,非随机化研究 (NCT04504916) 招募了转移性三阴性乳腺癌,HR+乳腺癌,NSCLC,卵巢癌或胰腺癌的患者.
- 参与者在两种不同的剂量方案 (Q1/3W或Q2/3W) 中接受了齐洛维他马布维多丁.
- 主要终点是ORR通过盲目的独立中央审查;ROR1表达通过免疫组织化学分析.
主要成果:
- 招募了102名参与者. ORR是1% (HR+/HER2-乳腺癌中的一个部分反应) 在Q1/3W剂量和0%在Q2/3W剂量.
- 中位数无进展生存时间为2.3个月 (Q1/3W) 和1.9个月 (Q2/3W). 平均整体存活时间为8.3个月 (Q1/3W) 和5.5个月 (Q2/3W).
- 与治疗相关的不良事件发生在83%的参与者中,最常见的是疲劳 (29%) 和恶心 (28%). 周围神经病变发生在8%的患者中.
结论:
- 齐洛韦他马布维多丁在先前治疗的转移性固体瘤中表现出极少的抗瘤活性,只观察到单个部分反应.
- 抗体与药物结合物表现出可控的安全性,31%的参与者中断/减少剂量,7%的参与者终止治疗.
- 在可评估的患者样本中观察到有限的ROR1表达,只有非响应者表达表达.
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