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三葉草生物-B(02197.HK)公佈針對腫瘤化療相關性血小板減少症(CIT)的靶向藥物SCB-219M I期臨牀試驗的積極數據
格隆匯 12-29 07:06

格隆匯12月29日丨三葉草生物-B(02197.HK)發佈公吿,在一項評估一類新藥SCB-219M的I期臨牀試驗中獲得了積極的安全性、有效性和藥代動力學初步數據,SCB-219M是通過CHO細胞生產的一種創新型包含血小板生成素受體激動劑(TPO-RA)模肽的雙特異性Fc融合蛋白靶向藥物,用於腫瘤患者化療引起的血小板減少症(“CIT”)。

本項I期臨牀試驗是一項多中心、開放性、劑量爬坡和劑量擴增的研究,探索SCB-219M經皮下注射在CIT患者中的安全性、耐受性、免疫原性、藥物動力學特徵及有效性。參加本臨牀試驗的研究中心包括四川大學華西醫院腫瘤中心,四川省人民醫院和成都市第六人民醫院。三葉草生物計劃於2024年啟動Ib期臨牀試驗,評估SCB-219M在CIT和CTIT(腫瘤治療引起的血小板減少症)患者中重複給藥的情況。

CIT是一種嚴重的、化療引起的併發症,可廣泛出現於腫瘤患者中。在接受標準化療方案的患者中,CIT的發生率可超過50%,並會對治療結果產生嚴重不利影響,導致化療時間延遲或化療劑量減少,以及潛在的致命性出血事件。

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