NCT06584071

A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC

A Phase Ib/II Clinical Trial to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetics of PM8002 Injection Combined With PM1009 Injection in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Biotheus Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma.

Detailed description

The study is divided into two parts. The first part is a phase Ib, single-arm study, which is planned to enroll 3-28 subjects. The second part is a phase II randomized, parallel-controlled, four-arm, open-label study, which is planned to enroll approximately 120 subjects.

Conditions

• HCC
• Liver Cancer

Interventions

Type	Name	Description
DRUG	PM8002	PM8002 via IV infusion, Q3W
DRUG	PM1009	PM8002 via IV infusion, Q3W
DRUG	atezolizumab	atezolizumab,1200mg, via IV infusion, Q3W
DRUG	bevacizumab	bevacizumab,15mg/kg, via IV infusion, Q3W

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-10-01
• Completion: 2027-12-01
• First posted: 2024-09-04
• Last updated: 2024-12-16