A Phase Ib/II Trial to Evaluate the Efficacy and Safety of HH-009 for the Treatment of FGF19-posi… (NCT07547553) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Phase Ib/II Trial to Evaluate the Efficacy and Safety of HH-009 for the Treatment of FGF19-positive Advanced or Unresectable HCC
China30 participantsStarted 2026-04-10
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* Participated in another clinical trial of investigational drugs or investigational medical devices within 28 days pr…
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: Through study completion, up to 2 years