浙江醫藥(600216.SH):HER2單抗-AS269偶聯注射液I期臨牀取得階段性進展
格隆匯12月13日丨浙江醫藥(600216.SH)公佈,近日,公司研發的重組人源化抗HER2單抗-AS269偶聯注射液(代號:ARX788)(原公告簡稱“抗HER2-ADC”)治療晚期乳腺癌的一項單中心、開放、劑量遞增的I期臨牀研究取得了階段性進展。
研究表明,在既往多次治療的HER2陽性晚期乳腺癌患者中,ARX788具有良好的耐受性。劑量1.5mg/kg三週一次給藥(Q3W)時,安全性良好。在51名受試者中,僅出現了3例與藥物相關的≥3級毒性。在從0.33mg/kgQ3W到1.5mg/kgQ3W的劑量爬坡及擴組試驗中,未觀察到劑量限制性毒性(DLT),且尚未達到最大耐受劑量(MTD)。
重組人源化抗HER2單抗-AS269偶聯注射液是公司於2013年6月14日與美國Ambrx公司簽署《合作開發和許可協議》合作研發的新一代單克隆抗體偶聯藥物,用於治療HER2陽性晚期乳腺癌和胃癌等,屬於創新生物技術藥物。
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