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A Study YL201 in Patients With Selected Advanced Solid Tumors

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研究单位: [1]MediLink Therapeutics (Suzhou) Co., Ltd. [2]Anhui Provincial Cancer Hospital,Hefei,Anhui,China [3]The First Affiliated Hospital of Anhui Medical University,Hefei,Anhui,China [4]The First Affiliated Hospital of USTC,Hefei,Anhui,China [5]The Second Hospital of Anhui Medical University,Hefei,Anhui,China [6]Chongqing University Cancer Hospital,Chongqing,Chongqing,China [7]Fujian Cancer Hospital,Fuzhou,Fujian,China [8]The First Affiliated Hospital of Xiamen University,Xiamen,Fujian,China [9]Gansu Provincial Cancer Hospital,Lanzhou,Gansu,China [10]Dongguan People''s Hospital,Dongguan,Guangdong,China [11]The Frist People''s Hospital of Foshan,Foshan,Guangdong,China [12]Sun Yat-sen University Cancer Center,Guangzhou,Guangdong,China,510000 [13]Affiliated Cancer Hospital and Institute of Guangzhou Medical University,Guangzhou,Guangdong,China [14]Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,Guangzhou,Guangdong,China [15]Jiangmen Central Hospital,Jiangmen,Guangdong,China [16]Yuebei People''s Hospital,Shaoguan,Guangdong,China [17]The Fifth Affiliated Hospital Sun Yat-Sen University,Zhuhai,Guangdong,China [18]The Second Affiliated Hospital of Guilin Medical University,Guilin,Guangxi,China [19]Liuzhou People''s Hospital,Liuzhou,Guangxi,China [20]Liuzhou Worker''s Hospital,Liuzhou,Guangxi,China [21]Affiliated Cancer Hospital of Guangxi Medical University,Nanning,Guangxi,China [22]The People''s Hospital of Guangxi Zhuang Autonomous Region,Nanning,Guangxi,China [23]The First Affiliated Hospital of Hainan Medical University,Haikou,Hainan,China [24]Affiliated Hospital of Chengde Medical University,Chengde,Hebei,China [25]Harbin Medical University Cancer Hospital,Haerbin,Heilongjiang,China [26]The First Affiliated Hospital of Henan University of Science and Technology,Luoyang,Henan,China [27]The First Affiliated Hospital of Xinxiang Medical University,Xinxiang,Henan,China [28]Henan Cancer Hospital,Zhengzhou,Henan,China [29]The First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,China [30]Union Hospital Tongji Medical College Huazhong University of Science and Technology,Wuhan,Hubei,China [31]Hunan Cancer Hospital,Changsha,Hunan,China [32]The Second Xiangya Hospital of Central South University,Changsha,Hunan,China [33]The First People''s Hospital of Changzhou,Changzhou,Jiangsu,China [34]The Affiliated Hospital of Nanjing University Medical School,Nanjing,Jiangsu,China [35]Nantong Tumor Hospital,Nantong,Jiangsu,China [36]Affiliated Hospital of Jiangnan University,Wuxi,Jiangsu,China [37]Jiangyin People''s Hospital,Wuxi,Jiangsu,China [38]Xuzhou Central Hospital,Xuzhou,Jiangsu,China [39]First Affiliated Hospital of Gannan Medical University,Ganzhou,Jiangxi,China [40]Jiangxi Cancer Hospital (Jiangxi Second People''s Hospital),Nanchang,Jiangxi,China [41]The First Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China [42]The First Hospital of Jilin University,Changchun,Jilin,China [43]Liaoning Cancer Hospital and Institute,Shenyang,Liaoning,China [44]The Frist Hospital of China Medical University,Shenyang,Liaoning,China [45]Binzhou Medical University Hospital,Binzhou,Shandong,China [46]Shandong Cancer Hospital and Institute,Jinan,Shandong,China [47]Shandong Provincial Hospital,Jinan,Shandong,China [48]Linyi Cancer Hospital,Linyi,Shandong,China [49]Shanxi Cancer Hospital,Datong,Shanxi,China [50]The Second Affiliated Hospital of the Chinese People''s Liberation Army Air Force Medical University,Xian,Shanxi,China [51]Sichuan Cancer Hospital,Chengdu,Sichuan,China [52]West China Hospital of Sichuan University,Huaxi,Sichuan,China [53]Tianjin Medical University Cancer Institute and Hospital,Tianjin,Tianjin,China [54]The First Affiliated Hospital, Zhejiang University School of Medicine,Hangzhou,Zhejiang,China [55]Zhejiang Cancer Hospital,Hangzhou,Zhejiang,China [56]Taizhou Hospital of Zhejiang Province,Taizhou,Zhejiang,China

关键词: Antibody-drug conjugate

研究目的:
This is A Multicenter, Open-Label, Phase 1/2 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients with Selected Advanced Solid Tumors. The study will include 2 parts: Phase 1 dose expansion stage (Part 1) followed by a Phase 2 stage with expanded sample size (Part 2). Part 1 will estimate the RP2D in dose expansion cohorts of patients with not linited to non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), nasopharyngeal carcinoma (NPC), esophageal squamous cell carcinoma (ESCC), metastatic castration-resistant prostate cancer (mCRPC), etc.. Part 2 will include patients with selected advanced solid tumor types enrolled at the RP2D to further assess the efficacy and safety of YL201.

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