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A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors
Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Summary
This is a first-in-human (FIH), phase 1, multicenter, open-label study of SKB571 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor .
Official title: A Phase 1 Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of SKB571 for Injection in Subjects With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
138
Start Date
2024-12-17
Completion Date
2027-12
Last Updated
2026-01-07
Healthy Volunteers
No
Conditions
Interventions
SKB571
SKB571 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.
Locations (15)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Affliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Shandong Cancer Hospital
Jinan, Shandong, China
Guangxi Medical University Cancer Hospital
Linyi, Shandong, China
Si Chuan Cancer Hospital
Chengdu, Sichuan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Bei Jing Cancer Hospital
Beijing, China
Chongqing University Cancer Hospital
Chongqing, China
Shanghai East Hospital
Shanghai, China
Shanghai Pulmonary Hospital
Shanghai, China
Zhongshan Hospital
Shanghai, China