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

Part of paid clinical trials in Glendale, California.

Sponsor
Shanghai Henlius Biotech
Study ID
NCT07176650
Phase
PHASE1
Status
Recruiting
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Conditions

  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • HLX13 — DRUG
    Patients will receive HLX13 (3 mg/kg) treatment on the first day of each 3-week cycle, up to 4 cycles.
  • Yervoy — DRUG
    Patients will receive US-sourced YERVOY® (3 mg/kg) treatment on the first day of each 3-week cycle, up to 4 cycles.
  • OPDIVO — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 25, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
246 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HLX13 Group
  • Active Comparator: US-sourced YERVOY® Group

Primary Outcome Measure

Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d) after the 1st dose [ Time Frame: from time 0 to 21 days after the 1st dose (3 weeks) ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Los Angeles Cancer NetworkGlendaleCalifornia91204-
Oncology Physicians Network (OPN) - Los Alamitos /OPN HealthcareGlendaleCalifornia91203-
Cancer Specialists of North FloridaJacksonvilleFlorida32256-
D&H National Research Centers, LLCMargateFlorida33063-
Mid Florida Hematology and oncology CenterOrange CityFlorida32763-
Florida Clinical Trials GroupPlantationFlorida33322-
Florida Clinical Trials GroupTamaracFlorida33321-
HCA Research Institute, LLCBrentwoodTennessee37027-
Oncology ConsultantsHoustonTexas77030-
American Oncology Network Vista Oncology Division/Physician Partner AssociateOlympiaWashington98506-
Northwest Medical Specialties PLLC (NWMS)TacomaWashington98405-

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Los Angeles Cancer Network· Glendale, CAOncology Physicians Network (OPN) - Los Alamitos /OPN Healthcare· Glendale, CACancer Specialists of North Florida· Jacksonville, FLD&H National Research Centers, LLC· Margate, FLMid Florida Hematology and oncology Center· Orange City, FLFlorida Clinical Trials Group· Plantation, FL

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