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

NCT07547553 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-16

No results posted yet for this study

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.

Conditions

  • Advanced or Unresectable Hepatocellular Carcinoma (HCC)

Interventions

DRUG

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

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

DRUG

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

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

Sponsors & Collaborators

  • Huahui Health

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-19
Primary Completion
2028-10-30
Completion
2028-10-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07547553 on ClinicalTrials.gov