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A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors
Sponsor: Shanghai Henlius Biotech
Summary
This is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety and immunogenicity of HLX18 and OPDIVO® in patients with resected esophageal or gastroesophageal junction cancer (EC/GEJC), melanoma (MEL), or urothelial carcinoma (UC).
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic Profile, Efficacy, Safety and Immunogenicity of HLX18 vs. OPDIVO® (US-sourced OPDIVO®) in Multiple Resected Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
174
Start Date
2026-07-15
Completion Date
2028-06-13
Last Updated
2026-07-27
Healthy Volunteers
No
Interventions
HLX18
Participants will receive HLX18 (480 mg) on Day 1 of each 4-week cycle
OPDIVO®
Participants will receive OPDIVO® (480 mg) on Day 1 of each 4-week cycle
Locations (7)
Fujian Medical University Union Hospital
Fuzhou, China
The First Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, China
The Second Hospital of Tianjin Medical University
Tianjin, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China