Clinical Research Directory

Main Inclusion Criteria: * Histologically confirmed diagnosis of unresectable or metastatic HCC, not amenable to a curative treatment approach. * Measurable disease as per RECIST v1.1 as determined by the Investigator based upon local radiologist assessment. * Must have failed one line of prior systemic treatment for unresectable or metastatic HCC containing an approved anti PD (L)-1 checkpoint inhibitor (CPI) with a minimum treatment duration of 12 weeks exposure for the CPI with no documented progression in this period. * Age ≥ 18 years on the day of signing the informed consent. * Life expectancy of at least 3 months as assessed by the Investigator. * ECOG performance status ≤1. * Child-Pugh score of A6 or better. Main Exclusion Criteria: * Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma. * More than 1 line of prior systemic treatment for unresectable or metastatic HCC. * Received or completed any palliative radiotherapy for symptoms within 28 days of the first dose of IMP. * Expected to require any other form of antineoplastic therapy during the trial. * Clinically active inflammatory bowel disease, active diverticulitis, intra-abdominal abscess, and/or gastrointestinal obstruction. * Known history of other prior malignancy unless participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy. * Known or detected clinically active central nervous system (CNS) involvement by HCC or other tumors. * Have one of the following cardiovascular risk factors: myocardial infarction, peri/myocarditis, or history of ischemic stroke in the past 3 months before planned treatment start, uncontrolled heart failure, uncontrolled ventricular arrhythmia, QT interval corrected for heart rate using Fridericia's formula interval ≥ 470 ms regardless of sex. * An active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start. * Comedication with metformin or metformin-containing antidiabetics in participants with type II diabetes. * Chronic systemic corticosteroid treatment for other reasons. * Prior liver or other organ transplantation.