在mCRPC中启动伊非那他玛德鲁克替康与化疗的3期试验

转移性阉割抵抗性前列腺癌（mCRPC）是前列腺癌进展的严重阶段，治疗难度大且预后较差。尽管已有多种疗法，但患者仍面临疾病进展和生存率低的挑战。因此，探索新型治疗方案成为当前研究的重点。伊非那他玛德鲁克替康作为一种B7-H3定向抗体药物偶联物，具有靶向肿瘤细胞的潜力，为mCRPC患者提供了新的治疗方向。

IDate-Prostate 01是一项全球多中心、开放标签的3期临床试验，旨在评估伊非那他玛德鲁克替康与标准化疗药物多西他赛在mCRPC患者中的疗效和安全性。该试验计划招募约1440名患者，主要终点包括总生存期（OS）和放射学无进展生存期（rPFS）。I/II期试验结果表明，伊非那他玛德鲁克替康在mCRPC患者中表现出良好的抗肿瘤活性，ORR达25%，中位缓解持续时间为6.4个月，中位OS为13.5个月。这些数据支持其进入3期试验，并可能改变现有治疗格局。

该试验的启动标志着伊非那他玛德鲁克替康开发进程的重要进展，也为mCRPC患者带来了新的希望。如果结果显示其优于传统化疗，将可能成为一线治疗方案。未来需关注试验结果及长期随访数据，进一步验证其安全性和有效性，推动其在临床中的广泛应用。

来源: urologytimes

原文链接：原文

参考文献

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