智通财经APP讯，复宏汉霖(02696)发布公告，近日，本公司自主研发的西妥昔单抗注射液生物类似药HLX05-N(重组抗EGFR人鼠嵌合单克隆抗体注射液)(HLX05-N)在转移性结直肠癌(mCRC)患者中的1期临床研究于中国境内(不包括中国港澳台地区)完成首例患者给药。
本研究是一项在KRAS/NRAS野生型且BRAF V600E无突变的转移性结直肠癌参与者中，比较HLX05-N与美国及欧盟来源Erbitux®联合化疗(mFOLFOX6) 治疗的多中心、随机、双盲、平行对照1期临床研究。参与者将按1:1:1随机分配至HLX05-N组、美国来源Erbitux®组或欧盟来源Erbitux®组，并根据 ECOG体能状态和性别进行分层。前三个周期，各组参与者将接受相应研究药物联合化疗;此后，美国或欧盟来源Erbitux®组参与者将在盲态下转换为 HLX05-N并继续联合化疗，直至达到方案规定的停药标准。本研究的主要目的是评估HLX05-N与Erbitux®在单次和多次静脉输注后的药代动力学(PK)相似性，次要目的是比较两者的药代动力学(PK)特征、有效性、安全性和免疫原性。
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.