康方生物-B(09926.HK):AK117聯合AK112聯合或不聯合化療治療晚期惡性腫瘤Ib/II臨牀研究獲批開展
格隆匯1月10日丨康方生物-B(09926.HK)發佈公吿,公司自主研發的新型腫瘤免疫治療新藥Ligufalimab(CD47單克隆抗體,研發代號:AK117)聯合Ivonescimab(PD-1/VEGF雙特異性抗體,研發代號:AK112)已經獲得中國國家藥品監督管理局藥品審評中心(CDE)批准,開展聯合或不聯合化療治療晚期惡性腫瘤的Ib/II期臨牀研究,旨在評估Ligufalimab聯合Ivonescimab聯合或不聯合化療治療晚期惡性腫瘤的安全性、耐受性、藥物動力學、免疫原性以及抗腫瘤活性。
該臨牀研究的II期階段主要目標人羣為消化道腫瘤患者。此前,Ligufalimab聯合Ivonescimab已經開展了主要目標人羣為頭頸部惡性腫瘤患者的Ib/II期臨牀研究。
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