研究单位:[1]Shanghai Junshi Bioscience Co., Ltd.[2]Beiijng Cancer Hospital,Beijin,Beijing,China,100000[3]The First Affiliated Hospital of Fujian Medical University,Fuzhou,Fujian,China,350000[4]Sun Yat-Sen University Cancer Center,Guangzhou,Guangdong,China,510060[5]Sun Yat-Sen University Cancer Center,Guangzhou,Guangdong,China,510060[6]The First Affiliated Hospital of Guangdong Pharmaceutical University,Guangzhou,Guangdong,China,510699[7]Sun Yat-Sen University Cancer Center,Guangzhou,Guangong,China,510060[8]Affiliated Hospital of Hebei University,Baoding,Hebei,China,071030[9]Harbin medical University cancer hospital,Harbin,Heilongjiang,China,150000[10]Henan Cancer Hospital,Zhengzhou,Henan,China,450003[11]Henan Cancer Hospital,Zhengzhou,Henan,China,450003[12]The First Affiliated Hospital of Zhengzhou University,Zhenzhou,Henan,China,450000[13]Union Hospital Tongji Medical College Huazhong University of Science and Techonoly,Wuhan,Hubei,China,430022[14]Nanjing Drum Tower Hospital,Nanjing,Jiangsu,China,210008[15]Affiliated Hospital of Jiangnan University,Wuxi,Jiangsu,China,214000[16]Xuzhou Central Hospital,Xuzhou,Jiangsu,China,221009[17]Liaoning Cancer Hospital & Institute,Shenyang,Liaoning,China,110801[18]Shandong Tumor Hospital,Jinan,Shandong,China,250117[19]Shanghai Pulmonary Hospital,Shanghai,Shanghai,China,200433[20]West China Hospital Sichuan University,Chengdu,Sichuan,China,610000[21]Cancer Hospital of the University of Chinese Academy of Sciences,Hangzhou,Zhejiang,China,310005[22]Sun Yat-sen University Cancer Center,Guangzhou,China
研究目的:
This is an open label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, immunogenicity and preliminary efficacy of JS201 in the patients with advanced malignant tumors who have progression after or during the standard of care, or no effective standard therapeutic regimen. This study is divided into three phases: dose-escalation phase, dose expansion phase, and clinical expansion phase.