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
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.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Liver Cancer Trials on Trialify →