創勝集團-B(06628.HK):CLAUDIN18.2單克隆抗體TST001聯合順鉑及吉西他濱用於一線治療膽道癌IIA期研究完成首例患者給藥
格隆匯2月28日丨創勝集團-B(06628.HK)發佈公吿,其Claudin18.2單克隆抗體TST001聯合順鉑及吉西他濱用於一線治療未經系統性治療的局部晚期或轉移性膽道癌患者的中國 IIa期研究成功完成首例患者給藥。公司是全球首家探索Claudin 18.2靶向劑用於治療膽道癌的潛力的公司。膽道癌為較罕見的惡性腫瘤,包括膽管癌及膽囊癌。
根據披露,膽管癌又分為肝外膽管癌及肝內膽管癌。在膽道癌的治療中,根治性切除是早期患者的標準及唯一療法。然而,大多數患者在診斷的時候,癌症就已經進入轉移期,因此不能接受手術切除。就膽道癌而言,可用於該等患者的療法相當有限,從而存在大量臨牀需求缺口。
該IIa期臨牀試驗是一項對TST001的開放、單臂、多中心的研究,旨在評估其對未經系統性治療的局部晚期或轉移性膽道癌患者的安全性、耐受性及抗腫瘤療效。該等患者將使用公司開發並經中心實驗室驗證的專門檢測Claudin18.2而非 Claudin 18.1的免疫組織化學檢測法進行篩選。
執行副總裁、全球研發負責人兼首席醫學官石明博士表示:“膽道癌預後不良,而順鉑及吉西他濱的聯合療法是一線治療的標準療法。我們使用專有的IHC抗體進行測試的結果顯示,Claudin 18.2在一部分膽道癌患者的腫瘤中過度表達。由於 Claudin18.2靶向抗體藥物與標準化療的聯合療法在一線胃癌中顯示出良好的抗腫瘤活性,在一線化療方案中加入TST001亦可能為Claudin18.2表達腫瘤的膽道癌患者提供更佳的治療效果。”
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