drugset / Trial / NCT06349980

A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

NCT06349980

Phase 2 Recruiting 117 enrolled Shanghai Henlius Biotech
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With or Without HLX53 (an Anti-TIGIT Fc Fusion Protein) in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

Timeline

Start
2024-08-05
Primary completion
2027-02-10
Completion
2027-02-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject HLX53 Protein / enzyme biologic 1000 mg Intravenous
Subject HLX53 Protein / enzyme biologic 2000 mg Intravenous
Subject Serplulimab Monoclonal antibody 300 mg Intravenous