drugset / Trial / NCT05290220

HLX07 Combination Therapy or Motherapy in Patient With Advanced Hepatocellular Carcinoma

NCT05290220

Phase 2 Unknown 60 enrolled Shanghai Henlius Biotech
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is conducted in patients with advanced hepatocellular carcinoma (HCC). This study includes three arms: A, B, and C. Arm A will receive HLX07 combination therapy with HLX10 and HLX04 as first line treatment. Arm B will receive HLX07 combination therapy with lenvatinib as second line treatment. Arm C will receive HLX07 monotherapy as third-line or above treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).

Timeline

Start
2022-08-01
Primary completion
2023-12-15
Completion
2024-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 12 mg Oral
Subject PIMURUTAMAB Monoclonal antibody 1500 mg Intravenous
Subject Serplulimab Monoclonal antibody 300 mg Intravenous