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和譽-B(02256.HK)完成ABSK011與抗PD-L1抗體聯合用藥臨牀II期試驗首例患者給藥
格隆匯 02-08 07:33

格隆匯2月8日丨和譽-B(02256.HK)宣佈, ABSK011(一款創新型FGFR4口服抑制劑)與羅氏製藥抗PD-L1抗體阿替利珠單抗 (atezolizumab)聯合用藥的臨牀II期試驗已完成首例患者給藥。該臨牀II期試驗針對的是FGF19過量表達的晚期或不可切除肝細胞癌(HCC)患者。

此臨牀試驗(ABSK-011-201、CTR20213287)已完成首例患者給藥,是一項在中國進行的II期、多中心、單臂、開放性臨牀試驗,旨在評估ABSK011聯合阿替利珠單抗(atezolizumab)用於治療FGF19過量表達的晚期或不可切除或轉移性肝細胞癌(HCC)患者的安全性及有效性。

根據披露,ABSK011是一款由和譽醫藥發現及開發、具備全球知識產權的新型FGFR4抑制劑。約30%HCC患者中出現FGF19-FGFR4信號通路異常激活,從而促進腫瘤生長並導致肝癌。在臨牀前研究中,ABSK011顯示出抑制FGFR4的高效力,具有優良的選擇性及理化特性。ABSK011單一療法的臨牀試驗目前正在進行中。

研究表明,腫瘤精準療法及腫瘤免疫療法相結合的聯合療法展現出更好的有效性及安全性。隨着ABSK011與阿替利珠單抗(atezolizumab)聯合用藥研究的發展,公司希望加快在中國的臨牀開發,並將這種具潛在價值的治療方法普惠廣大癌症患者。 

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