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A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity 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
2026-06-30
Completion Date
2028-06-13
Last Updated
2026-04-08
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