A Randomized, Open-Label, Multicenter, Phase Ib/II Registration Trial to Observe and Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HH-009 Injection in FGF19-Positive Participants With Advanced or Unresectable Hepatocellular Carcinoma (HCC) Who Have Experienced Progressive Disease After Prior Systemic Therapy
This is a randomized, open-label, multicenter Phase Ib/II registration trial designed to evaluate the efficacy and safety of HH-009 in patients with FGF19-positive hepatocellular carcinoma (HCC). The study will also assess pharmacokinetics, pharmacodynamics, immunogenicity, and exploratory biomarkers. Approximately 30 patients with FGF19-positive advanced HCC will be enrolled. Eligible participants will be randomized 1:1 to receive HH-009 at either 20 mg/kg or 30 mg/kg Q3W as monotherapy. Treatment will continue until disease progression, unacceptable toxicity, initiation of new anticancer therapy, study withdrawal, completion of two years of treatment, loss to follow-up, death, or other protocol-specified reasons, whichever occurs first.
• Voluntary participation in a clinical trial and signed informed consent.
• Ages 18 to 75 years (inclusive of the boundaries), male or female.
• Participants with advanced or unresectable HCC confirmed by pathological histology or diagnosed in accordance with the clinical criteria specified in the National Health Commission guidelines, with the following additional requirements:
‣ Participants with HCC who have experienced progressive disease after prio systemic therapy;
⁃ Tumor tissue IHC testing for FGF19 was positive (confirmed by central laboratory);
⁃ Child-Pugh class A or class B (Child-Pugh score ≤7) ;
⁃ Barcelona Clinic Liver Cancer (BCLC) stage B or C
• ECOG score 0 or 1
• Have at least one measurable lesion according to RECIST v1.1.
• Life expectancy ≥ 12 weeks.
• Adequate organ and bone marrow function.
• Participants with HCV infection, whose HCV-RNA levels are above the lower limit of detection at the study site, are eligible if antiviral therapy is initiated prior to the first dose administration.
• Participants with hepatitis B virus (HBV) infection must have HBV DNA \< 104 cps/mL or 2,000 IU/mL.
• Participants (including partners of the male participants) are willing to use effective contraception from the screening period until 6 months after the last investigational product administration.