智通财经APP讯，复宏汉霖(02696)发布公告，近日，一项HLX22(重组人源化抗HER2单克隆抗体注射液)(HLX22)联合德曲妥珠单抗治疗HER2低表达HR阳性的局部晚期或转移性乳腺癌的2期临床研究于中国境内(不包括港澳台地区，下同)完成首例患者给药。
本研究是一项多中心的2期临床研究，旨在评估HLX22联合德曲妥珠单抗治疗经标准治疗后疾病进展或不可耐受毒性反应的，HER2低表达HR阳性的局部晚期或转移性乳腺癌患者的疗效和安全性。符合条件的受试者将接受HLX22(15mg/kg，静脉注射)联合德曲妥珠单抗(5.4mg/kg，静脉注射)治疗。该研究的主要终点为独立影像评估委员会(IRRC)基于RECIST v1.1评估的客观缓解率(ORR)和无进展生存期(PFS);次要终点包括研究者评估的客观缓解率(ORR)和无进展生存期(PFS)、总生存期(OS)、独立影像评估委员会(IRRC)及研究者评估的缓解持续时间(DOR)、安全性、药代动力学、免疫原性和生物标志物。
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