研究单位:[1]MediLink Therapeutics (Suzhou) Co., Ltd.[2]Peking University Cancer Hospital,Beijing,Beijing,China[3]Cancer Hospital, Chinese Academy of Medical Sciences,Beijing,Beijinig,China[4]Chongqing University Cancer Hospital,Chongqing,Chongqing,China[5]Fujian Provincial Cancer Hospital,Fuzhou,Fujian,China[6]The First Affiliated Hospital of Fujian Medical University,Fuzhou,Fujian,China[7]The First Hospital of Lanzhou University,Lanzhou,Gansu,China[8]Sun Yat-Sen University Cancer Center,Guangzhou,Guangdong,China[9]Affiliated Cancer Hospital of Guangxi Medical University,Nanning,Guangxi,China[10]Guangxi Zhuang Autonomous Region People''s Hospital,Nanning,Guangxi,China[11]The First Affiliated Hospital of Hainan Medical College,Haikou,Hainan,China[12]The Fourth Hospital of Hebei Medical University,Shijiazhuang,Hebei,China[13]Cancer Hospital Affiliated to Harbin Medical University,Ha''erbin,Heilongjiang,China[14]Henan Cancer Hospital,Zhengzhou,Henan,China[15]The First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,China[16]Hubei Provincial Cancer Hospital,Wuhan,Hubei,China[17]Union Hospital Tongji Medical College HuaZhong University of Science Technology,Wuhan,Hubei,China[18]Hunan Cancer Hospital,Changsha,Hunan,China[19]Jiangxi Cancer Hospital,Nanchang,Jiangxi,China[20]The First Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China[21]The First Hospital of Jilin University,Changhua,Jilin,China[22]Liaoning Provincial Cancer Hospital,Shenyang,Liaoning,China[23]Shandong Cancer Hospital and Institute,Jinan,Shandong,China[24]Linyi Central Hospital,Linyi,Shandong,China[25]Zaozhuang Municipal Hospital,Zaozhuang,Shandong,China[26]West China Hospital of Sichuan University,Chengdu,Sichuan,China[27]West China Hospital, Sichuan University,Sichuan,Sichuan,China[28]Tianjin Cancer Hospital,Tianjin,Tianjin,China[29]The First Affiliated Hospital, Zhejiang University School of Medicine,Hangzhou,Zhejiang,China[30]Zhejiang Provincial Cancer Hospital,Hangzhou,Zhejiang,China[31]Taizhou Hospital of Zhejiang Province,Taizhou,Zhejiang,China
研究目的:
This is a phase 1, multicenter, open-label stydy to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Combination with Serplulimab with or without Platinum-based Chemotherapy in Selected Subjects with Advanced Solid Tumors conducted in China. The study will include 2 parts: a dose escalation part (Part 1) followed by a cohort expansion part (Part 2). Part 1 will estimate the safety, tolerability and MTD/RED(s) of YL201 in combination with serplulimab with or without platinum-based chemotherapy in selected subjects with advanced solid tumors. Part 2 will estimate the efficacy of YL201 in combination with serplulimab with or without platinum-based chemotherapy in selected subjects with advanced solid tumors.