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Not yet recruiting NCT06841185

A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX13 with YERVOY As a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma

Phase III Interventional Hepatocellular Carcinoma (HCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HLX13, US-sourced YERVOY®, EU-sourced YERVOY®.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma (HCC). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Multicenter, Double-Blind, Parallel-Controlled Integrated Phase I/III Clinical Study to Evaluate the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY® and EU-Sourced YERVOY®) As a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma

Overview

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

Detailed description

This study includes three treatment groups. Patients will be randomly assigned at a 2:1:1 ratio to the HLX13, US-sourced YERVOY®, or EU-sourced YERVOY® group to receive the treatment of IMPs in combination with nivolumab.

Patients with good tolerability and disease control will receive HLX13 or YERVOY® in combination with nivolumab on the first day of every 3 weeks for up to 4 cycles. PK and immunogenicity blood sampling will be conducted during the treatment period. After the four treatment cycles, all subjects will be subsequently treated with nivolumab monotherapy until investigator-assessed disease progression, initiation of a new anti-neoplastic therapy, withdrawal of informed consent, death, unacceptable toxicity, or up to 1 year after randomization, whichever occurs first.

Interventions

  • Drug HLX13
    HLX13 (3 mg/kg) and nivolumab (1 mg/kg) treatment on the first day of each cycle, every 3 weeks with a total of 4 cycles
  • Drug US-sourced YERVOY®
    US-sourced YERVOY® (3 mg/kg) and nivolumab (1 mg/kg) treatment on the first day of each cycle, every 3 weeks with a total of 4 cycles
  • Drug EU-sourced YERVOY®
    EU-sourced YERVOY® (3 mg/kg) and nivolumab (1 mg/kg) treatment on the first day of each cycle, every 3 weeks with a total of 4 cycles

Primary outcome measures

  • Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d) [Time frame: Up to Day 21]
  • Area under the serum concentration-time curve within a dosing interval at steady-state (AUCss) [Time frame: Up to Day 85]
  • Best Objective Response Rate (ORR) up to Week 24 (assessed by Independent Radiology Review Committee [IRRC] based on RECIST v1.1) [Time frame: Up to Week 24]
Secondary outcome measures (12)
  • Maximum serum drug concentration (Cmax) after the first dose [Time frame: Up to Day 21]
  • Trough serum drug concentration (Ctrough) after the first dose [Time frame: Up to Day 21]
  • Time to reach maximum serum drug concentration (Tmax) after the first dose [Time frame: Up to Day 21]
  • Elimination half-life (t1/2) after the first dose [Time frame: Up to Day 21]
  • Total clearance (CL) after the first dose [Time frame: Up to Day 21]
  • Volume of distribution during terminal phase (Vz) after the first dose [Time frame: Up to Day 21]
  • Time to reach maximum serum drug concentration at steady state (Tmax, ss) [Time frame: Up to Day 85]
  • Maximum serum drug concentration at steady state (Cmax, ss) [Time frame: Up to Day 85]
  • Minimum serum drug concentration at steady state (Cmin, ss) [Time frame: Up to Day 85]
  • Elimination half-life (t1/2) at steady state [Time frame: Up to Day 85]
  • Volume of distribution at steady state (Vss) [Time frame: Up to Day 85]
  • Total clearance at steady state (CLss) [Time frame: Up to Day 85]

Eligibility criteria

Inclusion criteria

  • Histologically or cytologically diagnosed relapsed metastatic or advanced hepatocellular carcinoma not eligible for surgical or locoregional therapies according to the diagnostic criteria of the American Association for the Study of Liver Diseases (AASLD).
  • At least one measurable lesion as assessed by IRRC based on RECIST v1.1 within 4 weeks prior to the first dose in this study.
  • No systemic therapy for relapsed metastatic or advanced hepatocellular carcinoma prior to screening.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
  • Child-Pugh Class A.
  • Normal major organ functions.
  • Women of childbearing potential should use highly effective methods of contraception during the study and within 5 months after the last study treatment; Male subjects capable of fathering a child must agree to use at least one highly effective method of contraception for the duration of the study and for at least 7 months after the last study treatment.

Exclusion criteria

  • With other histopathological types of hepatocellular carcinoma.
  • History of hepatic encephalopathy.
  • Clinically significant ascites.
  • Patients with tumor thrombus at the main portal vein, left or right portal (either or both) vein branch, or inferior vena cava.
  • Presence of the central nervous system disorders at screening, except subjects who have previously received treatment for brain metastases can participate in the study treatment if their clinical symptoms have been stable for at least 4 weeks.
  • Evidence of portal hypertension with bleeding esophageal or gastric varices within 6 months prior to the randomization.
  • Known active or suspected autoimmune diseases.
  • Active co-infection with both hepatitis B and C, or hepatitis D infection in subjects with hepatitis B.
  • Uncontrolled cardiovascular diseases within 6 months.
  • Known interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and severe lung function abnormalities that may impede the investigators' diagnosis and management of drug-related pulmonary toxicity prior to screening.
  • Patients who have received any T-cell costimulatory agents or immune checkpoint blockade therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other agents that target T cells.
  • Patients who have other conditions not suitable for inclusion per investigator's judgments.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06841185 · HLX13-HCC301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗