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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.

Phase 2RecruitingRenJi HospitalNCT06978933Data as of May 2026

Treatment: ABSK-011This 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.

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Extracted 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

Min 1 prior line

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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