By Fineline Cube 
Shanghai-based Abbisko Therapeutics Co., Ltd. (HKG: 2256) announced the dosing of the first patient in a regulatory clinical study for its novel small-molecule FGFR4 inhibitor, irpagratinib. The study focuses on patients with advanced or unresectable hepatocellular carcinoma (HCC).
Clinical Trial Design
The Phase Ib study is multi-center, randomized, double-blinded, and placebo-controlled. It evaluates the efficacy and safety of irpagratinib plus best supportive care (BSC) versus placebo in FGF19-overexpressing HCC patients who have previously been treated with immune checkpoint inhibitors (ICIs) and multi-targeted kinase inhibitors (mTKIs).
Preclinical Results
Earlier Phase Ib data demonstrated significant efficacy with irpagratinib in combination with atezolizumab. The combination showed a 50% objective response rate (ORR) in FGF19-positive HCC patients post-ICI therapy.
Market Potential
Irpagratinib received Breakthrough Therapy Designation in China in May 2024. It represents a potential precision therapy for FGF19-overexpressing HCC, targeting a population with currently no approved targeted treatment options globally.-Fineline Info & Tech