OncoMatch/Clinical Trials/NCT06978933
FGF19 Overexpression Combination Unified Study in HCC-19
Is NCT06978933 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies ABSK-011 for hcc - hepatocellular carcinoma.
Treatment: ABSK-011 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Biomarker criteria
Required: FGF19 overexpression (overexpression positive)
The central laboratory test report for FGF19 overexpression positive
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy
Progression of disease confirmed by imaging after receiving at least one line of systemic therapy
Cannot have received: FGFR4 inhibitor
Has received prior therapy with FGFR4 or pan-FGFR inhibitors
Cannot have received: pan-FGFR inhibitor
Has received prior therapy with FGFR4 or pan-FGFR inhibitors
Lab requirements
Blood counts
Kidney function
Liver function
Adequate organ and marrow function defined by study-specified laboratory tests
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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