NCT06822985

QL1706 As Second-line Treatment in Patients with Advanced Hepatocellular Carcinoma

The Efficacy and Safety of QL1706 As Second-line Treatment in Advanced Hepatocellular Carcinoma Patients Refractory to First-line Therapy: a Single-arm, Phase I Study

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Wan-Guang Zhang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I trial to assess the safety and preliminary efficacy of QL1706 in Treating Advanced Hepatocellular Carcinoma Patients refractory to prior immunotherapy.

Detailed description

Immune checkpoint inhibitors (ICIs) have produced encouraging results in patients with hepatocellular carcinoma (HCC). Nonetheless, single-agent ICIs are effective in only 15% to 20% of HCC patients. According to the phase 3 LEAP-002 trial, lenvatinib combined with pembrolizumab provides a limited survival advantage over lenvatinib. In China, local treatments combined with tyrosine kinase inhibitors (TKIs) and anti-PD-1 antibodies have been used as the first-line treatment of advanced HCC. However, due to the heterogeneity of cancer, patient responses to monotherapy or combination therapy vary considerably, and only some patients benefit from such therapy. Hence, there is an unmet need to investigate the appropriate treatment for the rapidly expanding group of patients with advanced HCC who had tumor progression on prior anti-PD-1 therapies. QL1706 (PSB205) is a single bifunctional MabPair (a novel technical platform) product consisting of two engineered monoclonal antibodies (anti-PD-1 IgG4 and anti-CTLA-4 IgG1), with a shorter elimination half-life (t1/2) for CTLA-4. The Single-arm, single-center study aims to evaluate the safety and efficacy of QL1706 in treating advanced HCC refractory to prior PD-1 immune checkpoint inhibitors.

Conditions

• HCC - Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	QL1706	Drug: QL1706 7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-02-12
• Last updated: 2025-02-12

Locations

1 site across 1 country: China