Core Viewpoint - The company, Junshi Biosciences, has announced the completion of the first patient dosing in a 1b/2 clinical study of HLX43 in combination with HLX07 or Hansizhuang for patients with advanced or metastatic colorectal cancer in mainland China [1][2] Group 1 - The study aims to evaluate the safety, tolerability, and efficacy of HLX43 combined with HLX07 or Hansizhuang in patients with advanced or metastatic colorectal cancer [2] - The study consists of two parts: the first part includes a safety lead-in phase and a dose expansion phase, utilizing a 3+3 dose escalation design [2] - The primary objective of the first phase is to assess the safety and tolerability of different dose levels of HLX43 combined with HLX07, while secondary objectives include pharmacokinetics, immunogenicity, efficacy, and potential biomarkers [2] Group 2 - The second phase is a randomized, multi-center, open-label study evaluating HLX43 at two dose levels combined with fixed-dose HLX07, focusing on efficacy in metastatic colorectal cancer patients [2] - The secondary objectives of the second phase include evaluating safety and tolerability, pharmacokinetics, immunogenicity, and potential predictive or resistance biomarkers [2] - Additionally, the second part assesses HLX43 combined with fixed-dose Hansizhuang in metastatic colorectal cancer patients, with similar objectives regarding efficacy and safety [2]
复宏汉霖(02696.HK)：注射用HLX43联合HLX07或汉斯状®在晚期或转移性结直肠癌患者中开展的1b/2期临床研究于中国大陆完成首例患者给药