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.
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…
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