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

NCT07518043 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2026-04-15

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-08-12
Completion
2028-06-13
FDA Drug
Yes

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07518043 on ClinicalTrials.gov