复宏汉霖(02696.HK):HLX10联合HLX07用于HNSCC治疗的2期临床研究于中国大陆完成首例患者给药
格隆汇 7 月 29日丨复宏汉霖-B(02696.HK)发布公告,今日,公司重组抗PD-1人源化单克隆抗体注射液(“HLX10”)联合重组抗EGFR人源化单克隆抗体注射液(“HLX07”)用于复发或转移性头颈部鳞状细胞癌(HNSCC)治疗的2期临床研究于中国大陆完成首例患者给药。
该研究为一项评价HLX10联合HLX07治疗晚期复发性或转移性头颈部肿瘤患者的临床疗效及安全性的开放性、2期临床试验。试验主要目的是评价 HLX10和HLX07联合治疗晚期头颈部鳞状细胞癌的第16周客观缓解率及安全性。其次旨在评价其他疗效终点、免疫原性与药代动力学特征。探索性目的包括监别治疗反应和╱或耐药性的生物标志物。
HLX10为公司自主研发的创新型生物药,拟用于实体瘤治疗,目前正进一步探索用于慢性B型肝炎(即慢性乙型肝炎)治疗的可能性。HLX07为公司自主研发的针对EGFR靶点的改良型创新生物药,有望用于结直肠癌、鼻咽癌等多种实体瘤适应症治疗。截至该公告日,于中国大陆尚无同类联合疗法获国家药品监督管理局上市批准。
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