研究单位：[1]Keymed Biosciences Co.Ltd[2]Sun Yat-sen University[3]Sun Yat-sen University Cancer Center (SYSUCC),Guangzhou,Guangdong,China[4]Henan Cancer Hospital,Zhengzhou,Henan,China[5]West China Hospital of Sichuan University,Chengdu,Sichuan,China[6]Affiliated Hospital of Hebei University,Baoding,China[7]Hunan Cancer Hospital,Changsha,China[8]Sichuan Cancer Hospital,Chengdu,China[9]Chongqing University Cancer Hospital,Chongqing,China[10]Fujian Cancer Hosppital,Fuzhou,China[11]Fujian Medical University Union Hospital,Fuzhou,China[12]The First Affiliated Hospital of Fujian Medical University,Fuzhou,China[13]Guangdong Provincial People's Hospital,Guangzhou,China[14]Sun Yat-sen Memorial Hospital, Sun Yat-sen University,Guangzhou,China[15]The First Affiliated Hospital, Sun Yat-sen University,Guangzhou,China[16]Hainan General Hospital,Haikou,China[17]The First Affiliated Hospital, Zhejiang University School of Medicine,Hangzhou,China[18]Harbin Medical University Cancer Hospital,Harbin,China[19]The Second Hospital of Anhui Medical University,Hefei,China[20]Affiliated Hospital of Jining Medical University,Jining,China[21]Lanzhou University Second Hospital,Lanzhou,China[22]The First Affiliated Hospital of Henan University of science and Technology,Luoyang,China[23]Meizhou People's Hospital,Meizhou,China[24]Jiangxi Cancer Hospital,Nanchang,China[25]Huashan Hospital, Fudan University,Shanghai,China[26]Liaoning Cancer Hospital & Institute,Shenyang,China[27]The First Hospital of China Medical University,Shenyang,China[28]The Forth Hospital of Hebei Medical University and Hebei Tumor Hospital,Shijiazhuang,China[29]The Second Affiliated Hospital of Soochow University,Suzhou,China[30]Hubei Cancer Hospital,Wuhan,China[31]Tongji Hospital Tongji Medical College of HUST,Wuhan,China[32]The First Affiliated Hospital of Xiamen University,Xiamen,China[33]The Affiliated Hospital of Xuzhou Medical University,Xuzhou,China[34]The First Affiliated Hospital of Zhengzhou University,Zhengzhou,China
研究目的：
This is a multi-center, open-label, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of CMG901. The dose escalation part (Part A) will determine the MTD of CMG901 in subjects with relapsed and/or refractory advanced solid tumor for which there is no available standard therapy likely to confer clinical benefit, or the subject is not a candidate for such available therapy based on a modified 3+3 dose escalation design (an accelerated dose titration design followed by traditional 3+3 dose escalation design). The dose expansion part (Part B) will evaluate the preliminary anti-tumor activity and safety of CMG901 in subjects with Claudin 18.2 positive gastric cancer (GC), gastroesophageal junction (GEJ) cancer, and pancreatic cancer who have relapsed and/or are refractory to approved therapies.
