Dose-escalation phase is designed to determine the DLTs (Dose-limiting toxicity) and recommended phase II dose (RP2D) and characterize the safety, tolerability, pharmacokinetics (PK) and Pharmacodynamics (PD) of SY-4798. Other dose regimens may be explored based on the analysis of emerging PK and safety data. At this study phase, SY-4798 will be administered orally once daily (QD) in 28-day treatment cycles to adult patients with advanced solid tumor.~Dose-expansion phase is designed to evaluate the anti-tumor activity (ORR and DOR) of SY-4798 in patients with FGF19+ advanced tumor.
This is a Phase 1, open-label and multicenter study of SY-4798, a highly specific and potent inhibitor of FGFR4, in patients with advanced solid tumor. This study has two phases: dose-escalation phase and dose-expansion phase.