NCT07518043

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Esophageal and/or Cardia Cancer
• Melanoma
• Urothelial Carcinoma (UC)

Interventions

Type	Name	Description
DRUG	HLX18	Participants will receive HLX18 (480 mg) on Day 1 of each 4-week cycle
DRUG	OPDIVO®	Participants will receive OPDIVO® (480 mg) on Day 1 of each 4-week cycle

Timeline

• Start date: 2026-06-30
• Primary completion: 2027-08-12
• Completion: 2028-06-13
• First posted: 2026-04-08
• Last updated: 2026-04-15

Regulatory

• FDA-regulated drug study