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A Phase 1 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Advanced Solid Tumors

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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.

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