Shanghai-based biotech company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received clearance from the US Food and Drug Administration (FDA) to commence a Phase I clinical study of its next-generation FGFR4 mutant inhibitor, ABSK012, for the treatment of advanced solid tumors.
Objectives of the Phase I Study
The Phase I study aims to evaluate the safety, tolerability, and pharmacokinetics of ABSK012 in patients with advanced solid tumors that exhibit specific genetic alterations. These include FGF19 overexpressing hepatocellular carcinoma (HCC), FGFR4 mutant rhabdomyosarcoma (RMS), and other related conditions.
Preclinical Success and Orphan Drug Designation
Preclinical studies have demonstrated that ABSK012 possesses significant anti-tumor activity and exhibits favorable pharmacokinetic properties. Recognizing its potential for treating rare diseases, the US FDA awarded ABSK012 an orphan drug designation (ODD) in April of this year for the treatment of soft-tissue sarcoma.-Fineline Info & Tech
