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

NCT06841185 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: HLX13-HCC301
• Study Type: interventional
• Target: 656
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

Ipilimumab Biosimilar

Outcome Measures

Primary Outcomes (3)

• Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d)

  Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  Up to Day 21

• Area under the serum concentration-time curve within a dosing interval at steady-state (AUCss)

  Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  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)

  Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  Up to Week 24

Secondary Outcomes (26)

• Maximum serum drug concentration (Cmax) after the first dose

  Up to Day 21

• Trough serum drug concentration (Ctrough) after the first dose

  Up to Day 21

• Time to reach maximum serum drug concentration (Tmax) after the first dose

  Up to Day 21

• Elimination half-life (t1/2) after the first dose

  Up to Day 21

• Total clearance (CL) after the first dose

  Up to Day 21

Study Arms (3)

HLX13 group

EXPERIMENTAL

Recombinant anti-CTLA-4 fully human monoclonal antibody injection developed by Shanghai Henlius Biotech, Inc.

Drug: HLX13

US-sourced YERVOY® group

ACTIVE COMPARATOR

US-sourced ipilimumab

Drug: US-sourced YERVOY®

EU-sourced YERVOY® group

ACTIVE COMPARATOR

EU-sourced ipilimumab

Drug: EU-sourced YERVOY®

Interventions

HLX13 DRUG

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

HLX13 group

US-sourced YERVOY® DRUG

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

US-sourced YERVOY® group

EU-sourced YERVOY® DRUG

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

EU-sourced YERVOY® group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 24, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): June 6, 2027
• Study Completion (Estimated): May 5, 2028
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share