HH-009 Phase 1b/II HCC Trial, 30 Patients
Summary
A randomized, open-label, multicenter Phase 1b/II registration trial evaluating HH-009 in approximately 30 patients with FGF19-positive advanced or unresectable hepatocellular carcinoma has been registered on ClinicalTrials.gov. Eligible participants will be randomized 1:1 to receive HH-009 monotherapy at either 20 mg/kg or 30 mg/kg Q3W until disease progression, unacceptable toxicity, or other protocol-specified reasons.
“Approximately 30 patients with FGF19-positive advanced HCC will be enrolled.”
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What changed
This document registers a Phase 1b/II clinical trial for HH-009, an investigational drug for FGF19-positive hepatocellular carcinoma, on ClinicalTrials.gov. The trial will enroll approximately 30 patients at multiple sites, randomized to two dosing arms (20 mg/kg or 30 mg/kg Q3W) as monotherapy.
For pharmaceutical sponsors, clinical investigators, and patients considering trial participation, this registration establishes the formal protocol parameters and eligibility criteria. Trial sponsors should ensure IRB approvals and IND filings are current and aligned with the registered protocol version.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Phase Ib/II Trial to Evaluate the Efficacy and Safety of HH-009 for the Treatment of FGF19-positive Advanced or Unresectable HCC
Phase 1 NCT07547553 Kind: PHASE1 Apr 23, 2026
Abstract
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: Will receive HH-009 injection 20 mg/kg, Q3W, Will receive HH-009 injection 30 mg/kg, Q3W
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