NCT07075419

JDB153 Combined With Penpulimab for Hepatocellular Carcinoma After Standard Treatment Failure

A Phase Ib/II Clinical Trial of JDB153 Combined With Penpulimab for the Treatment of Hepatocellular Carcinoma Refractory to Standard Therapy

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of JDB153 combined with Penpulimab in patients with hepatocellular carcinoma after standard treatment failure.

Detailed description

This study is a single-arm, single-center, exploratory clinical trial aimed at evaluating the safety and efficacy of JDB153 combined with Penpulimab in patients with hepatocellular carcinoma after standard treatment failure.

Conditions

• Refractory Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	JDB153	JDB153 is administered orally at doses of 600 mg twice daily (1200 mg total daily dose) or 500 mg twice daily (1000 mg total daily dose) based on safety and tolerability assessment.
DRUG	Penpulimab	Penpulimab is administered by intravenous infusion at a dose of 200 mg once every 3 weeks (Q3W).

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-07-01
• Completion: 2027-08-01
• First posted: 2025-07-20
• Last updated: 2025-07-20