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復宏漢霖-B(02696.HK):HLX55用於無其他標準治療的晚期實體瘤治療的1期臨牀研究完成首例患者給藥
格隆匯 03-03 22:24

格隆匯3月3日丨復宏漢霖-B(02696.HK)公佈,近日,公司注射用HLX55 單抗("HLX55")用於無其他標準治療的晚期實體瘤治療的1期臨牀研究於中國台灣地區完成首例患者給藥。

該項研究為一項開放、國際多中心、劑量探索/擴展的1期臨牀試驗,主要目的是在第一階段評估HLX55在標準治療耐藥的晚期或轉移性實體瘤患者中開展的安全性,確定最大耐受劑量以及2期試驗推薦劑量,在第二階段進一步評估HLX55在經組織學證實為c-MET突變、擴增或過度表達且對標準治療耐藥的晚期或轉移性實體瘤患者中的有效性及安全性。次要目的包括評估不同劑量水平的HLX55在各受試組的藥代動力學特徵、替代性藥效學生物標誌物肝細胞生長因子(Hepatocyte growth factor,HGF)的血清濃度變化以及HLX55的免疫原性。探索性目的包括識別可預測HLX55有效性的c-MET相關生物標誌物。

HLX55是公司經Kolltan Pharmaceuticals, Inc.授予許可在亞洲多個地區獨家開發及商業化的生物創新藥,是一款針對c-MET靶點開發的人源化單克隆抗體。臨牀前研究結果表明,靶向HGF/c-MET(天然配體肝細胞生長因子╱c-MET)信號通路的HLX55在體內外具有抗腫瘤作用和良好的安全性,這些數據為後續開展人體臨牀試驗提供了科學基礎。2019年9月,HLX55用於無其他標準治療的晚期實體瘤治療獲台灣衞生福利部原則同意在中國台灣地區進行臨牀試驗。2019年10月,HLX55用於轉移性或複發性實體瘤治療的臨牀試驗申請獲國家藥品監督管理局批准。

截至公告日,在全球範圍內尚無與HLX55同類的藥品上市,HLX55上市後有望為醫生提供更多的治療選擇,惠及更多腫瘤患者。

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