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RECRUITING
NCT07518043
PHASE1

A Study 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

2026-07-15

Completion Date

2028-06-13

Last Updated

2026-07-27

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

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