研究单位:[1]Risen (Suzhou) Pharma Tech Co., Ltd.[2]Beijing Cancer Hospital,Beijing,China[3]The First Affiliated Hospital of Bengbu Medical College,Bengbu,China[4]Jilin Cancer Hospital,Changchun,China[5]Jilin University First Hospital,Changchun,China[6]Sichuan Cancer Hospital,Chengdu,China[7]Chongqing University Cancer Hospital,Chongqing,China[8]Fujian Cancer Hospital,Fuzhou,China[9]Fujian Medical University Union Hospital,Fuzhou,China[10]Sir Run Run Shaw Hospital,Hangzhou,China[11]Zhejiang Cancer Hospital,Hangzhou,China[12]Harbin Medical University Cancer Hospital,Harbin,China[13]Shandong Cancer Hospital & Institute,Jinan,China[14]Affiliated Hospital of Jining Medical College,Jining,China[15]Linyi Cancer Hospital,Linyi,China[16]The First Affiliated Hospital of Henan University of Science and Technology,Luoyang,China[17]Guangxi Medical University Cancer Hospital,Nanning,China[18]The Affiliated Hospital of Qingdao University,Qingdao,China[19]Affiliated Cancer Hospital of Fudan University,Shanghai,China[20]Liaoning Cancer Hospital&Institute,Shenyang,China[21]Suining Central Hospital,Suining,China[22]Hubei Cancer Hospital,Wuhan,China[23]Ceneral Hosipital of Ningxia Medical University,Yinchuan,China[24]Henan Cancer Hospital,Zhengzhou,China
研究目的:
This is an open phase I/Ib clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and initial efficacy of RP903 in patients with advanced malignancies who have failed standard treatment or have no standard treatment options. The study was divided into two parts: dose escalation and dose extension (Phase Ia) and clinical extension (Phase Ib).