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

Akeso1 site in 1 country32 target enrollmentJanuary 27, 2021

ConditionsHepatocellular Carcinoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Hepatocellular Carcinoma
Sponsor: Akeso
Enrollment: 32
Locations: 1
Primary Endpoint: Objective response rate (ORR)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

January 27, 2021

End Date

August 2, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Akeso

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed written informed consent form voluntarily.
•Histologically or cytologically documented hepatocellular carcinoma.
•BCLC stage C, and non-resectable BCLC stage B .
•At least one measurable lesion according to RECIST criteria.
•ECOG of 0 or
•Adequate organ function.
•Estimated life expectancy of ≥3 months.
•For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent

Exclusion Criteria

•Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc.
•History of hepatic encephalopathy or liver transplantation.
•Clinical significance of hydrothorax, ascites or pericardial effusion.
•Central nervous system metastases and/or carcinomatous meningitis.
•Any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy.
•Occurred arteriovenous thromboembolic events within 6 months before the first administration.
•Tumor volume \> 50% liver volume; portal vein tumor thrombus or inferior vena cava tumor thrombus.
•Inadequately controlled arterial hypertension.
•Attack of symptomatic congestive heart failure (LVEF\<50%); History of congenital long QT syndrome.
•Known presence or history of interstitial lung disease or required hormone treatment interstitial lung disease.

Outcomes

Primary Outcomes

Objective response rate (ORR)

Time Frame: Up to 2 years

ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.

Secondary Outcomes

Progression-free survival (PFS)(Up to 2 years)
Disease control rate (DCR)(Up to 2 years)
Number of participants with adverse events (AEs)(the time of informed consent signed through 90 days after the last dose of AK104 and Lenvatinib)
Duration of response (DoR)(Up to 2 years)