復宏漢霖(02696.HK):HLX22用於HER2過表達晚期實體瘤治療的1期臨牀研究結果顯示其安全性及耐受性良好
格隆匯9月30日丨復宏漢霖(02696.HK)宣佈,近日,HLX22(抗人表皮生長因子受體-2(HER2)人源化單克隆抗體注射液)("HLX22")已於近日於中國大陸完成1期臨牀研究,其在一項於HER2過表達晚期實體瘤患者中開展的1期臨牀研究中展現了良好的安全性及耐受性。
本研究為一項開放標籤、劑量遞增的1期臨牀研究,旨在評估HLX22在HER2過表達晚期實體瘤患者中的安全性、耐受性、藥代動力學特徵和初步療效。研究採用3+3劑量遞增方法,合格患者將接受靜脈輸注不同劑量(3、10、25mg/kg)的HLX22的治療,每三週一次。本研究的主要終點為發生不良事件的患者比例和HLX22的最大耐受劑量(MTD)。次要終點包含藥代動力學參數、免疫原性及初步療效。試驗結果顯示,HLX22具有良好的安全性和耐受性。研究過程中未發生劑量限制毒性(DLT),HLX22的MTD為25 mg/kg
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