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開拓藥業-B(09939.HK):ALK-1單抗聯合KN046治療晚期或難治性實體腫瘤臨試完成首例患者給藥

格隆匯11月2日丨開拓藥業-B(09939.HK)發佈公告,公司ALK-1單抗(GT90001)聯合康寧傑瑞製藥-B(09966.HK)自主研發的重組人源化PD-L1/CTLA-4雙特異性抗體KN046在中國臺灣進行的治療晚期或難治性實體腫瘤的Ib/II期臨牀試驗完成首例患者入組及給藥。

根據披露,該臨牀試驗(NCT04984668)是一項兩階段、多中心、開放標籤的研究,旨在評估ALK-1單抗聯合KN046在晚期或難治性實體腫瘤(包括肝細胞癌(HCC)、胃癌(GC)、胃食管結合部腺癌(GEJ)、尿路上皮癌(UC)和食管鱗癌(ESCC))患者中的安全性、耐受性、藥代動力學(PK)和抗腫瘤活性。

ALK-1單抗是一種全人源化IgG2中和單克隆抗體,可抑制ALK-1/TGF-β信號轉導和腫瘤血管生成,且是公司於2018年2月自輝瑞公司獲得所有腫瘤領域全球獨家授權的潛在同類首創抗體。

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