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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]Guangdong Provincial Hospital of Chinese Medicine Guangzhou,Guangdong,China [3]Cancer Hospital,Chinese Academy of Medical Sciences Beijing,Beijing,China [4]Chongqing Cancer Hospital Chongqing,Chongqing,China [5]The First Hospital of China Medical University Guangzhou,Guangdong,China [6]Cancer Hospital affiliated to Shantou University Medical College Shantou,Guangdong,China [7]TeFiftlated Hosptal of Guangxi Medical University Nanning,Guangxi,China [8]Harbin Medical University Cancer Hospital Heerbin,Heilongiang,China

研究目的:
This study is a phase I/II study of single drug TJ004309 and PD-1 monoclonal antibody injection 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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