drugset / Trial / NCT07010497

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

NCT07010497 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject irpagratinib Small molecule 150 mg Oral
Subject irpagratinib Small molecule 200 mg Oral