在患有固体瘤骨转移的患者中JMT103的有效性和安全性:一项随机的Ib期临床试验
Ran Ran1, Hongtao Li2, Tao Sun3
1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University Cancer Hospital and Institute, Beijing, China.
International journal of cancer
|January 24, 2025
概括
这项研究评估了三种JMT103对骨转移的剂量方案,发现显著抑制了骨周转率标志物. 在所有测试剂量中,JMT103表现出良好的安全性.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 生物化学 生物化学
背景情况:
- 骨转移显著影响患者的生活质量和固体瘤的预后.
- 需要有效的治疗来管理骨周转和相关并发症.
研究的目的:
- 评估三种JMT103用药方案在患有固体瘤骨转移的患者中的疗效和安全性.
- 评估JMT103对骨循环标记物和骨相关事件的影响.
主要方法:
- 一项随机研究涉及295名骨转移患者.
- 患者每4周服用120毫克,每8周服用120毫克或每8周服用180毫克的皮下JMT103.
- 主要终点是第13周尿液N-皮质 (uNTx/Cr) 调整为肌素的变化.
主要成果:
- 在第13周,所有三种JMT103疗法都显示了骨转化标记的显著降低,中位数降低范围从73.0%到80.0%.
- 与骨相关的事件很低,在3.1%至7.0%的患者中报告.
- 与治疗相关的常见不良事件包括低血症 (23.2%) 和低血症 (22.9%).
结论:
- 在患有固体瘤骨转移的患者中,JMT103有效地抑制了骨周转.
- 经过测试的JMT103剂量方案显示出良好的安全性.
- 作为治疗骨转移的治疗选择,JMT103显示出前景.
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