RecruitingPhase 2NCT06789848

Ligufalimab and Cadonilimab in Advanced Liver Cancers

Phase II Basket Trial of Ligufalimab (AK117) and Cadonilimab (AK104) in Advanced Hepatobiliary Cancers


Sponsor

University of Texas Southwestern Medical Center

Enrollment

64 participants

Start Date

Feb 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two immunotherapy drugs — ligufalimab and cadonilimab — for people with advanced liver cancers that have not responded well to other treatments. This includes both hepatocellular carcinoma (HCC, the most common primary liver cancer) and biliary tract cancers (cancers of the bile ducts or gallbladder). **You may be eligible if...** - You have been diagnosed with advanced hepatocellular carcinoma (HCC) confirmed by tissue biopsy or by established clinical criteria, OR biliary tract cancer (including bile duct or gallbladder cancer) confirmed by tissue biopsy - Your cancer is locally advanced or has spread, and surgery or local treatments are not possible - You have received prior treatment and the cancer has progressed, or you have not yet received any systemic treatment (depending on the cohort) - Your overall health and organ function meet the study requirements **You may NOT be eligible if...** - You have a specific rare subtype of liver cancer called fibrolamellar HCC - Your cancer has not been confirmed by the appropriate methods - You do not meet performance status or organ function requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLigufalimab

Ligufalimab (AK117) 45 mg/kg IV over 120 minutes on Day 1 every 3 weeks

DRUGCadonilimab

Cadonilimab (AK104) 10 mg/kg IV over 60 minuets at least 30 minutes after Ligufalimab on Day 1 every 3 weeks


Locations(1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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NCT06789848


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