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Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors
Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Summary
This is an open, multicenter study of phase I/II in Chinese subjects with unresectable locally advanced/metastatic solid tumors. It is divided into the dose escalation period and the cohort expansion period. A total of 8 dose groups (Q3W on the first day of intravenous administration) were designed in the dose escalation period. The initial dose was 1.0mg/kg administered Q3W, with a DLT observation period of 21 days. In the dose expansion phase, 7 cohorts were established.
Official title: Phase I/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of JSKN003 in Chinese Subjects With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
725
Start Date
2023-03-15
Completion Date
2026-12-31
Last Updated
2026-02-02
Healthy Volunteers
No
Conditions
Interventions
JSKN003
JSKN003 should be administered intravenously on the first day of each 3-week cycle.
Locations (34)
Beijing Cancer Hospital
Beijing, China
Beijing Friendship Hospital
Beijing, China
Beijing Luhe Hospital
Beijing, China
Hunan Cancer Hospital
Changsha, China
Fujian Cancer Hospital
Fuzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Sun Yat-sen University Cancer Prevention Center
Guangzhou, China
Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Affiliated Cancer Hospital of Harbin Medical University
Ha’erbin, China
Anhui Provincal Hospital
Hefei, China
Shandong Cancer Hospital
Jinan, China
Linyi City Cancer Hospital
Linyi, China
Linyi City People's Hospital
Linyi, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Gulou Hospital Affiliated to Nanjing University School of Medicine
Nanjing, China
Jiangsu Cancer Hospital
Nanjing, China
Jiangsu Provincial People's Hospital
Nanjing, China
The First Affiliated Hospital of Nanjing Medical University/Jiangsu Provincial People's Hospital
Nanjing, China
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, China
Nantong Cancer Hospital
Nantong, China
Affiliated Hospital of Qingdao University
Qingdao, China
Affiliated Cancer Hospital of Fudan University
Shanghai, China
Changhai Hospital
Shanghai, China
Fudan University Shanghai Cancer Center
Shanghai, China
Shanghai East Hospital
Shanghai, China
The Second Affiliated Hospital of Soochow University
Suzhou, China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Zhongnan Hospital of Wuhan University
Wuhan, China
Xuzhou Central Hospital
Xuzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China