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

Recruiting Phase 1 Phase 2 Interventional Study
Advanced or Unresectable Hepatocellular Carcinoma (HCC)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Huahui Health · Industry
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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 participan…
Trial Locations
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Eligibility Criteria
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 crite…
Contacts

Xiyu Zhang PM

18701650516

zhangxiyu@hhhbio.com

CONTACT