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基石藥業(02616.HK)公布CS1003試驗初步數據
阿思達克 09-20 17:48

基石藥業(02616.HK)公布,在第22屆中國臨床腫瘤學會,以口頭報告形式首次公佈了公司的在研抗PD-1單抗CS1003橋接I期試驗的初步數據。

CS1003初步安全性數據60mg和200mg兩個劑量水平均未觀察到劑量限制性毒性,且未達到最大耐受劑量;18例患者(94.7%)中發生了治療相關不良事件(「TRAE」),其中3例患者(15.8%)出現了3級及以上的TRAE,其餘均為1至2級。較常見的TRAE為乏力(26.3%)、血膽紅素升高(15.8%)、甲狀腺功能減退症(15.8%)和貧血(15.8%);及9例患者報告了至少一起免疫相關不良事件,其中較為常見的包括:乏力(15.8%)、甲狀腺功能減退症(15.8%)、甲狀腺功能亢進症(10.5%)和皮疹(10.5%)。

基石藥業董事長、執行董事兼首席執行官江寧軍指,很高興看到目前在Ia期試驗中已經取得了出色的初步數據,將繼續大力推進CS1003在全球的臨床開發。除了在中國與澳洲正在進行的項目之外,也已經獲得了美國的臨床試驗批准,未來還將進一步挖掘CS1003在與多種藥物聯合方面的獨特優勢和廣泛應用潛力。

CS1003-102是一項在中國開展的多中心、開放性的劑量遞增和適應症擴展的I期臨床研究。該研究於2018年11月啟動,旨在探索CS1003用於治療晚期腫瘤患者的安全性、藥代動力學特徵、免疫原性及初步抗腫瘤療效。

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