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

October 17, 2022 updated by: Akeso

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • The first affilited hospital zhejiang university school of medcine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 1.
  • 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.
  • Severe infections.
  • Receipt of any anti-tumor treatment, chemotherapy, targeted therapy, immunotherapy,
  • Enrollment of another clinical study within 4 weeks prior to the first administration of study drugs.
  • Unable to receive an enhanced CT or MRI scan of the liver.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AK104
AK104 15mg/kg IV every 3weeks (Q3W)
Biological: AK104
Subjects will receive AK104 until disease progression or for a maximum of 24 months
EXPERIMENTAL: AK104 and Lenvatinib
AK104 15 mg/kg IV every 3 weeks (Q3W) Lenvatinib 12mg weight≥60kg or 8mg weight<60kg,PO QD
Biological: AK104 lenvatinib
Subjects will receive AK104 and lenvatinib until disease progression or for a maximum of 24 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR)
Time Frame: Up to 2 years
The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.
Up to 2 years
Duration of response (DoR)
Time Frame: Up to 2 years
Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first
Up to 2 years
Progression-free survival (PFS)
Time Frame: Up to 2 years
Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first
Up to 2 years
Number of participants with adverse events (AEs)
Time Frame: the time of informed consent signed through 90 days after the last dose of AK104 and Lenvatinib
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment
the time of informed consent signed through 90 days after the last dose of AK104 and Lenvatinib

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akeso

Collaborators

Akeso Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Tingbo Liang, MD, The First Affiliated Hospital Zhejiang University School of Medcine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 27, 2021

Primary Completion (ACTUAL)

March 30, 2022

Study Completion (ANTICIPATED)

March 31, 2023

Study Registration Dates

First Submitted

January 24, 2021

First Submitted That Met QC Criteria

January 24, 2021

First Posted (ACTUAL)

January 28, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK104-209

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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