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A Phase I/II Study of TJ004309 for Advanced Solid Tumor

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研究单位: [1]I-Mab Biopharma Co. Ltd. [2]The First Affiliated Hospital of Anhui Medical University,Hefei,Anhui,China [3]Cancer Hospital, Chinese Academy of Medical Sciences,Beijing,Beijing,China [4]Army Medical Center of PLA,Chongqing,Chongqing,China [5]Chongqing Cancer Hospital,Chongqing,Chongqing,China [6]Guangdong Provincial People's Hospital,Guangzhou,Guangdong,China,510080 [7]Guangdong Provincial Hospital of Chinese Medicine,Guangzhou,Guangdong,China [8]Cancer Hospital affiliated to Shantou University Medical College,Shantou,Guangdong,China [9]The First Affiliated Hospital of Guangxi Medical University,Nanning,Guangxi,China [10]Harbin Medical University Cancer Hospital,Haerbin,Heilongjiang,China [11]Henan Cancer Hospital,Zhengzhou,Henan,China [12]Hubei Cancer Hospital,Wuhan,Hubei,China [13]Hubei Cancer Hospital,Wuhan,Hubei,China [14]Union Hospital, Tongji Medical College, Huazhong University of Science and Technology,Wuhan,Hubei,China [15]Union Hospital, Tongji Medical College, Huazhong University of Science and Technology,Wuhan,Hubei,China [16]Hunan Cancer Hospital,Changsha,Hunan,China [17]Hunan Cancer Hospital,Changsha,Hunan,China [18]Northern Jiangsu People''s Hospital,Yangzhou,Jiangsu,China [19]The Second Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China [20]The First Bethune Hospital of Jilin University,Changchun,Jilin,China,130021 [21]Liaoning Cancer Hospital and Institute,Shenyang,Liaoning,China [22]The First Hospital of China Medical University,Shenyang,Liaoning,China [23]The First Affiliated Hospital of Xi ''an Jiaotong University,Xi''an,Shaanxi,China [24]Fudan University Shanghai Cancer Center,Shanghai,Shanghai,China,200032 [25]Sichuan Cancer Hospital,Chengdu,Sichuan,China [26]Yunnan Cancer Hospital,Kunming,Yunnan,China [27]Sir Run Run Shaw Hospital, Zhejiang University School of Medicine,Hanzhou,Zhejiang,China

研究目的:
This study is a phase I/II study of single drug TJ004309 and Toripalimab combine treatment for Advanced solid tumor. This study include two stages. First stage is dose escalation and second stage is dose extension. The purpose of part A is to confirm the MTD or MED and the clinical dose. The purpose of part B is to observe the safety, effectiveness, Pharmacokinetics, pharmacodynamics and biomarker properties for effective subjects.

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