康方生物(09926.HK)CD47單抗完成I期爬坡並獲批開展聯合阿扎胞(甘)之臨牀研究
康方生物-B(09926.HK)公佈,公司自主研發的腫瘤免疫治療新藥二代CD47單克隆抗體(研發代號:AK117)已完成澳洲I期劑量爬坡試驗。
AK117在各個劑量爬坡隊列受試者(0.3毫克/千克至45毫克/千克每週一次給藥)中均未發生劑量限制性毒性(DLT)和未出現有臨牀意義的貧血,各隊列受試者對藥物耐受性良好,無需使用低劑量預激給藥。
同時,AK117獲得國家藥品監督管理局批準,開展聯合阿扎胞(甘)治療急性髓系白血病(AML)的Ib/II期臨牀研究。
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