晚期固体瘤患者的抗OX40抗体BAT6026:多中心I期研究
Huaqiang Zhou1, Yuxiang Ma2, Yongsheng Li3
1Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou 510060, China.
iScience
|June 16, 2025
概括
这一第一阶段研究发现,BAT6026,一种OX40单克隆抗体,对于晚期固体瘤患者来说是安全的. 该药物在可评估疗效的患者中显示出38.5%的疾病控制率.
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:
- OX40激动剂是一种有前途的免疫疗法.
- BAT6026是一种全人类IgG1 OX40单克隆抗体.
- 晚期固体瘤患者在标准治疗失败后往往只有有限的治疗选择.
研究的目的:
- 评估BAT6026在患有晚期固体瘤的患者中的安全性和耐受性.
- 为了确定进一步研究的推剂量.
- 为了评估BAT6026.6的初步有效性.
主要方法:
- 一个多中心的,开放的,I期剂量升级和扩展研究.
- 患者每3周内接受0.01-10毫克/公斤剂量的静脉注射BAT6026.
- 评估了安全性,耐受性和初步疗效.
主要成果:
- 总体而言,BAT6026在剂量范围 (0.01-10毫克/公斤) 中耐受性良好.
- 观察到一个足够的安全概况.
- 在可评估疗效的26名患者中,10名患者实现了稳定疾病,导致疾病控制率 (DCR) 为38.5%.
结论:
- 在患有晚期固体瘤的患者中,BAT6026显示出可接受的安全性和临床活性初步迹象.
- 需要进一步的研究,包括组合疗法和新的输送方法.
- 该研究支持在瘤学中继续开发BAT6026.
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