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

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.

Trial Details

NCT ID
NCT07176650
Phase
PHASE1
Sponsor
Shanghai Henlius Biotech
Status
RECRUITING
Cancer Type
Hepatocellular Carcinoma (HCC) Liver Cancer
Interventions
  • HLX13
  • Yervoy
  • OPDIVO
Locations (sample)
  • Glendale, California, United States|34.14251,-118.25508
  • Glendale, California, United States|34.14251,-118.25508
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Margate, Florida, United States|26.24453,-80.20644
  • Orange City, Florida, United States|28.94888,-81.29867

Key Eligibility Criteria

  • Subjects must have signed and dated an IRB/IEC-approved written informed consent form (ICF) in accordance with regulatory and institutional guideli…
  • Male or female, 18 years ≤ age ≤ 65 years at the time of signing the ICF.
  • Body weight: 50 kg-85 kg.
  • Histologically diagnosed hepatocellular carcinoma (HCC); and must have an advanced HCC, defined as: a) not eligible for curative surgical and/or lo…

For full eligibility, visit ClinicalTrials.gov.

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