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NOT YET RECRUITING
NCT07518043
PHASE1

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

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).

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

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