drugset / Trial / NCT07518043

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

NCT07518043

Phase 1 Not yet recruiting 174 enrolled Shanghai Henlius Biotech
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2026-06-30
Primary completion
2027-08-12
Completion
2028-06-13

Drugs

EvaluationDrugModalityDoseRoute
Subject HLX18 Unknown 480 mg
Comparator Nivolumab Monoclonal antibody 480 mg