康宁杰瑞制药-B(09966)：JSKN033用于治疗HER2表达的晚期或转移性实体瘤的I/II期临床试验在澳大利亚获批
康宁杰瑞制药-B(09966)发布公告，集团自主研发的用于治疗人表皮生长因子受体2(HER2)表达的晚期或转移性实体瘤的JSKN033的I/II期临床试验(JSKN033-101)已获得澳大利亚Bellberry临床伦理委员会批准。
JSKN033-101是一项开放、多中心的I/II期临床试验，包括两个阶段：(i)I期剂量递增阶段，旨在评估JKSN033对HER2表达晚期或转移性实体瘤患者的安全性、耐受性、药代动力学及初步疗效，并确定最大耐受剂量(MTD)及/或II期推荐剂量(RP2D);及(ii)II期剂量扩展阶段，旨在评估JSKN033在RP2D剂量下对 HER2表达消化道肿瘤的疗效及安全性。
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