FGF19 Overexpression Combination Unified Study in HCC-19

This study is designed prospectively to investigate the safety and efficacy of ABSK-011 and ABSK043 in patients with previously treated unresectable or metastatic hepatocellular carcinoma (HCC) harboring FGF19 overexpression. ABSK-011, an oral, selective FGFR4 inhibitor which can irreversibly bind to the target. ABSK043, is an orally available, selective and potent inhibitor targeting the interaction of PD-1 and PD-L1, Safety, tolerability, and preliminary efficacy of ABSK-011 or ABSK043 were explored in a phase 1 trial ABSK-011-101 (NCT04906434) and ABSK043-101 (NCT04964375) trial, respective

Trial Details

NCT ID
NCT06978933
Phase
PHASE2
Sponsor
RenJi Hospital
Status
RECRUITING
Cancer Type
Liver Cancer
Interventions
  • ABSK-011
Locations (sample)
  • Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

  • Patients with HCC confirmed by pathological histology or cytology, or meeting the clinical diagnostic criteria for HCC as the AASLD or Guidelines f…
  • Progression of disease confirmed by imaging after receiving at least one line of systemic therapy
  • The central laboratory test report for FGF19 overexpression positive.
  • ECOG performance status of 0 or 1;

For full eligibility, visit ClinicalTrials.gov.

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