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

NCT07010497 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

  • Carcinoma, Hepatocellular

Interventions

DRUG

irpagratinib

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.

Sponsors & Collaborators

  • Abbisko Therapeutics Co, Ltd

    collaborator INDUSTRY

  • Asan Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-16
Primary Completion
2029-03-31
Completion
2029-03-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07010497 on ClinicalTrials.gov