德琪醫藥-B(06996.HK)獲內地批准治療實體瘤藥物I期臨床試驗
德琪醫藥-B(06996.HK)公布,國家藥監局已批准ATG-022用於治療晚期及轉移性實體瘤的I期臨床試驗(CLINCH研究)。該研究的主要目的為評估ATG-022單藥的安全性及耐受性,以確認ATG-022的生物有效劑量、最大耐受劑量(MTD)和II期試驗的使用劑量(RP2D)。
ATG-022是一種靶向Claudin 18.2的抗體藥物偶聯物。Claudin為通常在細胞間緊密連接內表達以形成調節細胞滲透性的屏障的細胞黏附分子。在癌症中,Claudin會因為細胞極性改變而在細胞表面表達。Claudin 18.2異構體在多種原發性惡性腫瘤(包括胃癌、食管癌及胰腺癌)中過度表達。
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