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

Source: https://onco.cc/trials/nct07547553/  
OnCo record `nct07547553` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of Will receive HH-009 injection 20 mg/kg, Q3W in hepatocellular carcinoma, run by Huahui Health, now recruiting.

## Summary

A Phase Ib/II Trial to Evaluate the Efficacy and Safety of HH-009 for the Treatment of FGF19-positive Advanced or Unresectable HCC is a phase 1/2 interventional study registered as NCT07547553 by Huahui Health, with 30 participants planned, started 2026-05-19 and due to reach its primary completion in 2028-10-30. Interventions recorded: Will receive HH-009 injection 20 mg/kg, Q3W and Will receive HH-009 injection 30 mg/kg, Q3W.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT07547553
- Phase: 1/2
- Setting: 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
- Sponsor: Huahui Health
- Enrolled: 30

## Sources

- ClinicalTrials.gov NCT07547553: https://clinicaltrials.gov/study/NCT07547553

## Connected records

- cancers: [Hepatocellular carcinoma](https://onco.cc/cancers/hcc/)

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