信達生物-B(01801.HK)抗PD-1/HER2雙特異性抗體I期臨牀研究在中國完成首例患者給藥
格隆匯11月27日丨信達生物-B(01801.HK)公佈,公司和韓美製藥共同開發的針對程式性死亡受體1(PD-1)及人表皮生長因子受體-2(HER2)的重組全人源雙特異性抗 體(IBI-315)I期臨牀研究在中國完成首例患者給藥。
公告顯示,該臨牀研究是一項在中國開展的評估IBI-315治療HER2表達的晚期實體惡性腫瘤受試者的I期臨牀研究,其研究目的為評估IBI-315單藥及聯合化療在晚期實體惡性腫瘤受試者中的安全性、耐受性、初步有效性和II期研究推薦劑量(「RP2D」)。
當前,IBI-315是全球首個進入臨牀開發階段的PD-1/HER2雙特異性抗體,其將靶向治療與免疫治療作用機制相結合,以潛在提高抗腫瘤活性並增強抗腫瘤有效性。
因此,開發IBI-315具有重要價值。公司希望IBI-315這個全新的雙特性抗體藥物可以為患者提供新型和更有效的治療方案,以滿足患者未被滿足的臨牀需求,最終使更多患者受益。
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