康寧傑瑞(09966.HK)JSKN003獲美國藥監局批准開展一項II期臨床研究
康寧傑瑞製藥(09966.HK)公布,JSKN003已獲美國食品藥品監督管理局批准,在美國開展一項II期臨床研究(研究編號:JSKN003-202)。
JSKN003-202是JSKN003的一項隨機、開放式標籤、多中心的II期臨床研究,用於治療鉑耐藥復發性上皮性卵巢癌、原發性腹膜癌或輸卵管癌(統稱為鉑耐藥卵巢癌,「PROC」),且不限人表皮生長因子受體2(HER2)表達水平。此臨床試驗旨在評估JSKN003在上述人群中的療效和安全性,並確定推薦III期劑量。
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