亚盛医药(06855.HK)新药在中国获批一项Ib/II期临床试验
亚盛医药(06855.HK)公布,公司1类新药MDM2-p53抑制剂APG-115获得国家药品监督管理局药物审评中心(CDE)临床许可,将开展联合PD-1/PD-L1抑制剂治疗晚期脂肪肉瘤或其他晚期实体瘤患者的Ib/II期临床研究。
该项研究为针对晚期脂肪肉瘤或其他晚期实体瘤患者进行的全国多中心、开放性、联合治疗的Ib/II期研究,将分成两个阶段进行,Ib期为剂量探索阶段,旨在评估APG-115联合PD-1抑制剂(特瑞普利单抗)的安全性和耐受性;II期为剂量扩增,并在TP53野生型且MDM2扩增的晚期脂肪肉瘤患者中探索疗效。
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