基石药业(02616.HK)公布CS1003试验初步数据
基石药业(02616.HK)公布,在第22届中国临床肿瘤学会,以口头报告形式首次公布了公司的在研抗PD-1单抗CS1003桥接I期试验的初步数据。
CS1003初步安全性数据60mg和200mg两个剂量水平均未观察到剂量限制性毒性,且未达到最大耐受剂量;18例患者(94.7%)中发生了治疗相关不良事件(「TRAE」),其中3例患者(15.8%)出现了3级及以上的TRAE,其余均为1至2级。较常见的TRAE为乏力(26.3%)、血胆红素升高(15.8%)、甲状腺功能减退症(15.8%)和贫血(15.8%);及9例患者报告了至少一起免疫相关不良事件,其中较为常见的包括:乏力(15.8%)、甲状腺功能减退症(15.8%)、甲状腺功能亢进症(10.5%)和皮疹(10.5%)。
基石药业董事长、执行董事兼首席执行官江宁军指,很高兴看到目前在Ia期试验中已经取得了出色的初步数据,将继续大力推进CS1003在全球的临床开发。除了在中国与澳洲正在进行的项目之外,也已经获得了美国的临床试验批准,未来还将进一步挖掘CS1003在与多种药物联合方面的独特优势和广泛应用潜力。
CS1003-102是一项在中国开展的多中心、开放性的剂量递增和适应症扩展的I期临床研究。该研究於2018年11月启动,旨在探索CS1003用於治疗晚期肿瘤患者的安全性、药代动力学特徵、免疫原性及初步抗肿瘤疗效。
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