NCT05290220

HLX07 Combination Therapy or Motherapy in Patient With Advanced Hepatocellular Carcinoma

An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (A Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) Combination Therapy or Motherapy in Patient With Advanced Hepatocellular Carcinoma (HCC)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	HLX07	1500 mg
DRUG	HLX10	300 mg
DRUG	HLX04	15mg/kg
DRUG	lenvatinib	12 mg (BW≥60 kg) or 8 mg (BW \<60 kg)

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-12-15
• Completion: 2024-12-15
• First posted: 2022-03-22
• Last updated: 2022-05-03