Ligufalimab and Cadonilimab in Advanced Liver Cancers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
The goal of this clinical trial is to find out if the combination of Ligufalimab and Cadonilimab are effective in treating advanced hepatobiliary cancers that have failed prior therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histological confirmation of specific disease -Cohort A (HCC): Patient must have a diagnosis confirmed by histology or clinically by the American Association for the Study of Liver Diseases (AASLD) criteria in patients with cirrhosis. Known fibrolamellar HCC will be excluded.
Cohort B (BTC, biliary tract cancers): Patients must have histologically confirmed biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gall bladder cancers). Patients with combined HCC-cholangiocarcinoma may be enrolled in Cohort B.
Locally advanced or metastatic disease
Patients with locally advanced or metastatic disease must have disease deemed not amenable to surgical and/or locoregional therapies or patients who have progressed following surgical and/or locoregional therapies.
Disqualifiers
Prior liver transplant.
Known human immunodeficiency virus (HIV) positive (testing not required).
Use of any live vaccines against infectious diseases within 28 days of first dose of study drug administration.
History of trauma or major surgery within 28 days prior to the first dose of study drug administration. (Tumor biopsy or placement of central venous access catheter (eg, port or similar) is not considered a major surgical procedure).
Trial design
Design model
Parallel
Treatments tested in this trial
Ligufalimab
DrugLigufalimab (AK117) 45 mg/kg IV over 120 minutes on Day 1 every 3 weeks
Cadonilimab
DrugCadonilimab (AK104) 10 mg/kg IV over 60 minuets at least 30 minutes after Ligufalimab on Day 1 every 3 weeks
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Cohort A: Hepatocellular carcinoma (HCC) / Liver CancerExperimental treatment 2 interventions
Group B: Cohort B: Bile duct cancerExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Objective Response rate of combination ligufalimab and cadonilimab
To determine the best objective response rate assessed by RECIST guidelines (version 1.1) of combination ligufalimab and cadonilimab in patients with advanced hepatobiliary cancers previously exposed to anti-PD-1/L1 antibody treatments.
Time frame
Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 monthsSecondary outcomes
1
Overall survival of combination ligufalimab and cadonilimab
To determine the overall survival rate of response of combination ligufalimab and cadonilimab compared to historical controls assessed by RECIST guidelines (version 1.1)
Time frame
Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months2
Progression-free survival of combination ligufalimab and cadonilimab
To determine the progression-free survival rate of response of combination ligufalimab and cadonilimab compared to historical controls assessed by RECIST guidelines (version 1.1)
Time frame
udy treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months3
Duration of response of combination ligufalimab and cadonilimab
To determine the duration of response of combination ligufalimab and cadonilimab compared to historical controls assessed by RECIST guidelines (version 1.1)
Time frame
Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months4
Overall safety profile of combination ligufalimab and cadonilimab.
Safety profile of combination ligufalimab and cadonilimab will be measured by the number of participants with Adverse Events (AEs) (serious / non-serious) as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame
Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Texas Southwestern Medical Center
Lead sponsor
Akesobio
Collaborator
Josephine Hughes Sterling Foundation
Collaborator
Source ClinicalTrials.gov