凯洛斯制药有限公司近日公布了其ENV-105(carotuximab)在转移性去势抵抗性前列腺癌患者的二期临床试验中取得的积极安全结果。中期安全评估显示,这款CD105拮抗剂与标准激素疗法apalutamide联合使用时,前十名入组患者展现出极佳耐受性。关键发现包括:无剂量限制性毒性或意外不良事件报告,治疗相关副作用均可控。值得注意的是,研究中未观察到任何3级或4级毒性反应。这项试验目标招募100名参与者,目前正在雪松西奈医疗中心等多个地点推进。中间疗效数据预计于2025年9月出炉。基于这些进展,凯洛斯制药计划与监管机构沟通,探讨潜在的关键三期研究设计方案。
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