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FGF19 Overexpression Combination Unified Study in HCC-19

Study acronym: FOCUS-19
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
RenJi Hospital
190 trials monitored
See 2 trials at risk
Liver Cancer
1,598 trials monitored
See 71 trials at risk
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, respectively. This trial focuses on the efficacy of the combination of ABSK-011 and ABSK043 in patients with previously treated unresectable or metastatic HCC harboring FGF19 overexpression.
Trial Details
NCT Number NCT06978933
Lead Sponsor RenJi Hospital
Conditions
(from sponsor)		 HCC - Hepatocellular Carcinoma
Related terms Carcinoma, Hepatocellular
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov