RecruitingPhase 1NCT07518043

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

Sponsor

Shanghai Henlius Biotech

Enrollment

174 participants

Start Date

Jul 15, 2026

Study Type

INTERVENTIONAL

Conditions

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

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).

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called HLX18 and a drug called OPDIVO® for people with esophageal and/or cardia cancer, melanoma, and other related conditions. The study is currently recruiting participants at 7 locations. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHLX18

Participants will receive HLX18 (480 mg) on Day 1 of each 4-week cycle

DRUGOPDIVO®

Participants will receive OPDIVO® (480 mg) on Day 1 of each 4-week cycle

Locations(7)

Fujian Medical University Union Hospital

Fuzhou, China

The First Affiliated Hospital Zhejiang University School Of Medicine

Hangzhou, China

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, China

The Second Hospital of Tianjin Medical University

Tianjin, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Union Hospital, Tongji Medical College,Huazhong University of Science and Technology

Wuhan, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

View Full Details on ClinicalTrials.gov

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NCT07518043

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