NCT04728321

A Study of Anti-PD-1/CTLA-4 Bispecific AK104 Alone or in Combination With Lenvatinib in Advanced Hepatocellular Carcinoma

An Open-Label Multi-Center Phase II Study of Anti-PD-1/CTLA-4 Bispecific Antibody AK104 Alone or in Combination With Lenvatinib in Patients With Advanced Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

An open-label multi-center phase II study to evaluate the efficacy and safety of anti-PD-1/CTLA-4 bispecific antibody AK104 alone or in combination with lenvatinib in patients with advanced hepatocellular carcinoma.

Detailed description

This is a multi-center, multi-cohort, open-label phase 2 clinical study to evaluate the anti-tumor activity, safety, PK profile, immunogenicity and potential biomarkers of AK104 alone or in combination with for the treatment of advanced hepatocellular carcinoma

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	AK104 lenvatinib	Subjects will receive AK104 and lenvatinib until disease progression or for a maximum of 24 months
BIOLOGICAL	AK104	Subjects will receive AK104 until disease progression or for a maximum of 24 months

Timeline

• Start date: 2021-01-27
• Primary completion: 2022-08-02
• Completion: 2023-08-02
• First posted: 2021-01-28
• Last updated: 2024-04-25

Locations

1 site across 1 country: China