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.