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Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma

NCT07176650 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2026-03-16

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, parallel-controlled, phase I clinical study to evaluate the PK characteristics, safety, efficacy, and immunogenicity of HLX13 and US-sourced YERVOY® in patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

DRUG

HLX13

Patients will receive HLX13 (3 mg/kg) treatment on the first day of each 3-week cycle, up to 4 cycles.

DRUG

Yervoy

Patients will receive US-sourced YERVOY® (3 mg/kg) treatment on the first day of each 3-week cycle, up to 4 cycles.

DRUG

OPDIVO

Patients will receive EU-sourced OPDIVO® (EU-sourced nivolumab) (1 mg/kg) treatment on the first day of each 3-week cycle, up to 4 cycles. Subjects who may continue to benefit from OPDIVO® treatment as assessed by investigators will be subsequently treated with local-sourced OPDIVO® monotherapy every 4 weeks, up to 2 year after randomization.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-11-25
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

More Related Trials

Entities

Drugs
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 NCT07176650 on ClinicalTrials.gov