drugset / Trial / NCT07518043
A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HLX18 | Unknown | 480 mg | — |
| Comparator | Nivolumab | Monoclonal antibody | 480 mg | — |