Clinical Trial

A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors

Recruiting Phase 1
View on ClinicalTrials.gov →
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).
Protocol Amendment History 2 changes
critical Recruitment opened 2026-07-25
notable Trial sites expanded: 0 -> 7 locations 2026-07-25
Trial Details
NCT Number NCT07518043
Lead Sponsor Shanghai Henlius Biotech
Conditions Esophageal and/or Cardia Cancer, Melanoma, Urothelial Carcinoma (UC)
Enrollment 174 participants
Start Date 2026-07-15
Primary Completion 2027-08-12 (estimated)
Study Completion 2028-06-13 (estimated)
Updated on ClinicalTrials.gov 2026-07-27