A Phase Ib/II Trial to Evaluate the Efficacy and Safety of HH-009 for the Treatment of FGF19-positive Advanced or Unresectable HCC

This study is a randomized, open‐label, multi‐center Phase Ib/II registration clinicaltrial. The study aims to evaluate the efficacy and safety of HH‐009 in participants withFGF19‐positive HCC; meanwhile, PK, PD, and immunogenicity profiles will be analyzed, andrelevant biomarkers will be explored.Approximately 30 participants with advanced HCC who are FGF19‐positive and haveprogressed after systemic therapy failure will be enrolled. Eligible participants meetinginclusion / exclusion criteria will be randomly assigned in a 1:1 ratio to two dosegroups: HH‐009 20 mg/kg or 30 mg/kg.Eligible participants will receive HH‐009 monotherapy at a dose of 20 mg/kg or 30 mg/kgaccording to the randomly assigned HH‐009 dose group, administered once every 3 weeks(Q3W), until progressive disease, intolerable toxicity (except when tolerability isrestored after dose adjustment), initiation of new anticancer therapy, loss to follow‐up,death, withdrawal from the study, completion of 2 years of study treatment, or any otherreason (whichever occurs first).