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.

A Randomized, Double-blind, Multi-center, Phase II Study to Evaluate the Anti-tumor Efficacy, Safety and Tolerability of HLX53 (an Anti-TIGIT Fc Fusion Protein) Combined with Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) Compared to Placebo + Serplulimab + HLX04, in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 117 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	HLX53 (1000mg)	HLX53 will be administered by IV infusion at a fixed dose of 1000 mg on Day 1 of each 21-day cycle.
DRUG	HLX53 (2000mg)	HLX53 will be administered by IV infusion at a fixed dose of 2000 mg on Day 1 of each 21-day cycle.
DRUG	HLX10	HLX10 will be administered by IV infusion at a fixed dose of 300 mg on Day 1 of each 21-day cycle.
DRUG	HLX04	HLX04 will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
OTHER	Placebo	Placebo matching HLX53 will be administered by IV infusion on Day 1 of each 21-day cycle.

Timeline

• Start date: 2024-08-05
• Primary completion: 2027-02-10
• Completion: 2027-02-10
• First posted: 2024-04-05
• Last updated: 2024-12-18

Locations

1 site across 1 country: China