Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05744427
PHASE1/PHASE2

Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors

Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

View on ClinicalTrials.gov

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

Interventions

DRUG

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