在针对晚期NSCLC的I/II期单疗研究中,非传统抗体-药物结合物L-DOS47的安全性
Rodryg Ramlau1, Dariusz M Kowalski2, Aleksandra Szczęsna3
1Center of Pulmonary and Thoracic Surgery, Med-Polonia Sp. z o.o., Poznań, Poland.
Frontiers in oncology
|August 27, 2025
概括
在高剂量的非小细胞肺癌患者中,L- DOS47是一种针对CEACAM6的新型抗体- 药物结合物,显示出有前途的无进展存活率. 通过CEACAM6表达查,可以确定可能受益于这种治疗的患者.
科学领域:
- 癌症学
- 癌症治疗方法
- 瘤微环境
背景情况:
- 瘤中的酸度是癌症的标志.
- 在酸性瘤中CEACAM6的表达增加.
- L-DOS47针对CEACAM6并中和瘤的酸性.
研究的目的:
- 评估L-DOS47在晚期非小细胞肺癌 (NSCLC) 的安全性和耐受性.
- 确定L-DOS47的最大耐受剂量 (MTD) 和最佳剂量方案.
主要方法:
- 开放式,非随机的I/II期研究.
- 3+3剂量升级以发现MTD,然后进行II期剂量探索.
- 每周或每周两次使用.
主要成果:
- 耐受性高达13. 55μg/ kg;没有达到MTD.
- 没有观察到完全或部分反应.
- 较高的L- DOS47剂量 (≥5. 76μg/ kg) 与明显延长的无进展生存期 (PFS) 有关.
结论:
- 在NSCLC患者中,L- DOS47单一治疗是安全的和可以容忍的.
- 在较高剂量下观察到的延长PFS表明了剂量-益处关系.
- 通过CEACAM6表达查,可以确定可能受益于L- DOS47治疗的患者.
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