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

ConditionAdvanced or Unresectable Hepatocellular Carcinoma (HCC)

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorHuahui Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary participation in a clinical trial and signed informed consent.

Ages 18 to 75 years (inclusive of the boundaries), male or female.

Participants with HCC who have experienced progressive disease after prio systemic therapy;

Tumor tissue IHC testing for FGF19 was positive (confirmed by central laboratory);

Disqualifiers

Participated in another clinical trial of investigational drugs or investigational medical devices within 28 days prior to the first dose; or received anticancer treatment within the past 4 weeks before the first dose, or within five half-lives of the drug (whichever is shorter), including but not limited to chemotherapy, radiotherapy (allowing palliative radiotherapy completed at least two weeks prior to investigational product administration), targeted therapy, immunotherapy, or endocrine therapy; or received traditional Chinese medicine with anticancer indications within one week before the first dose.

The previous antitumor treatment-related toxicity has not yet recovered to ≤ grade 1 or baseline level

Previously received FGFR inhibitors, including FGFR4 inhibitors and pan-FGFR inhibitors.

Undergone major surgery (except biopsy) within 4 weeks prior to the first study dose of the investigational product, or surgical wounds not fully healed.

Trial design

Design model

Parallel

Treatments tested in this trial

Will receive HH-009 injection 20 mg/kg, Q3W
Drug
Will receive HH-009 injection 20 mg/kg monotherapy, Q3W
Will receive HH-009 injection 30 mg/kg, Q3W
Drug
Will receive HH-009 injection 20 mg/kg monotherapy, Q3W

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: HH-009 20 mg/kg groupExperimental treatment 1 intervention

Group B: HH-009 30 mg/kg groupExperimental treatment 1 intervention

Trial outcomes