RecruitingPhase 2NCT07010497

A Prospective Study to Evaluate the Safety and Efficacy of the Combination Therapy of Irpagratinib, Atezolizumab, and Bevacizumab in Patients With Hepatocellular Carcinoma

A PHASE 2, OPEN-LABEL STUDY OF IRPAGRATINIB IN COMBINATION WITH ATEZOLIZUMAB AND BEVACIZUMAB IN PATIENTS WITH ADVANCED OR UNRESECTABLE HEPATOCELLULAR CARCINOMA (IAPETUS)

Sponsor

Asan Medical Center

Enrollment

33 participants

Start Date

Mar 16, 2026

Study Type

INTERVENTIONAL

Conditions

Carcinoma, Hepatocellular

Summary

This is a phase 2, open-label study to evaluate the safety, tolerability and efficacy of Irpagratinib in combination with Atezolizumab and Bevacizumab in patients with advanced or unresectable HCC harboring FGF19 overexpression. This study composes two parts, a Safety Run-in part to evaluate safety and establish the dose of Irpagratinib for the triple combination, and an Expansion part to evaluate the preliminary efficacy and safety using Simon's two-stage design.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a three-drug combination — irpagratinib (a targeted therapy), atezolizumab (an immunotherapy), and bevacizumab (an anti-angiogenesis drug) — in patients with advanced liver cancer (hepatocellular carcinoma) that cannot be surgically removed. **You may be eligible if...** - You are 19 or older - You have advanced or inoperable liver cancer confirmed by biopsy or imaging - Your liver is still functioning adequately (Child-Pugh A) - You have not received prior systemic therapy for liver cancer **You may NOT be eligible if...** - You have had prior targeted therapy, immunotherapy, or chemotherapy for liver cancer - You have uncontrolled high blood pressure or significant heart disease - You have active hepatitis B or C that is not being controlled - You are pregnant or breastfeeding 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

DRUGirpagratinib

Patients will receive oral administration of ABSK-011 capsules in a repetitive dosing regimen for a period of 21 consecutive days as a cycle, either once daily or twice daily, until the investigators make a comprehensive assessment of imaging examinations, laboratory data, and the clinical condition of the patients, and determine that there is intolerable toxicity or disease progression.

Locations(1)

Asan Medical Center,

Seoul, South Korea

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NCT07010497

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