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Brief Title: A Phase I/II Study of TJ004309 for Advanced Solid Tumor
Official Title: A Phase I/II Study of Evaluating the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics and Curative Effect of Dose Escalation and Extension for Single Drug TJ004309 and Toripalimab Combine Treatment for Advanced Solid Tumor
Study ID: NCT04322006
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China
Army Medical Center of PLA, Chongqing, Chongqing, China
Chongqing Cancer Hospital, Chongqing, Chongqing, China
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, Guangdong, China
Cancer Hospital affiliated to Shantou University Medical College, Shantou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China
Harbin Medical University Cancer Hospital, Haerbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
The First Bethune Hospital of Jilin University, Changchun, Jilin, China
Liaoning Cancer Hospital and Institute, Shenyang, Liaoning, China
The First Hospital of China Medical University, Shenyang, Liaoning, China
The First Affiliated Hospital of Xi 'an Jiaotong University, Xi'an, Shaanxi, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Sichuan Cancer Hospital, Chengdu, Sichuan, China
Yunnan Cancer Hospital, Kunming, Yunnan, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hanzhou, Zhejiang, China