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复宏汉霖(02696.HK):用於头颈部鳞状细胞癌治疗临床研究完成首例患者给药
阿思达克 07-29 18:02
复宏汉霖(02696.HK)公布,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)用於复发或转移性头颈部鳞状细胞癌(HNSCC)治疗的2期临床研究於中国境内完成首例患者给药。

HLX10为公司自主研发的创新型生物药,拟用於实体瘤治疗,目前正进一步探索用於慢性B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,有望用於结直肠癌、鼻咽癌等多种实体瘤适应症治疗。

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徵。探索性目的包括监别治疗反应或耐药性的生物标志物。

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