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Brief Title: Clinical Study of JS201 in Patients With Advanced Malignant Tumors
Official Title: An Open-label, First-in-human, Dose Escalation and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of JS201 in Patients With Advanced Malignant Tumors
Study ID: NCT04956926
Brief Summary: This is an open label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, immunogenicity and preliminary efficacy of JS201 in the patients with advanced malignant tumors who have progression after or during the standard of care, or no effective standard therapeutic regimen. This study is divided into three phases: dose-escalation phase, dose expansion phase, and clinical expansion phase.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beiijng Cancer Hospital, Beijin, Beijing, China
The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China
Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, Guangdong, China
Sun Yat-Sen University Cancer Center, Guangzhou, Guangong, China
Affiliated Hospital of Hebei University, Baoding, Hebei, China
Harbin medical University cancer hospital, Harbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Henan Cancer Hospital, Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University, Zhenzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Techonoly, Wuhan, Hubei, China
Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China
Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China
Xuzhou Central Hospital, Xuzhou, Jiangsu, China
Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China
Shandong Tumor Hospital, Jinan, Shandong, China
Shanghai Pulmonary Hospital, Shanghai, Shanghai, China
West China Hospital Sichuan University, Chengdu, Sichuan, China
Cancer Hospital of the University of Chinese Academy of Sciences, Hangzhou, Zhejiang, China
Sun Yat-sen University Cancer Center, Guangzhou, , China