OncoMatch/Clinical Trials/NCT07327034
ABSK-011+BSC vs. Placebo+BSC in Previously Treated Advanced HCC With FGF19 Overexpression
Is NCT07327034 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies ABSK-011+BSC for hepatocellular carcinoma (hcc).
Treatment: ABSK-011+BSC — This is a randomized, double-blind, multicenter, Phase 2 study to evaluate the efficacy and safety of ABSK-011 plus BSC versus placebo plus BSC in advanced or unresectable hepatocellular carcinoma (HCC) patients with FGF19 overexpression who have received prior systemic therapy. Approximately 141 advanced or unresectable HCC patients with FGF19 overexpression who have received prior systemic therapy will be enrolled and randomized to experimental arm or control arm in a 2:1 ratio. Patients will receive assigned study treatment, every 28-day treatment cycle within 1 day of randomization until disease progression, intolerable toxicity, start of new anti-tumor therapy, death, patient refuse to continue treatment, loss to follow-up, or other reasons leading to treatment discontinuation. Immediate BICR review is required for patients with radiographic disease progression as assessed by the investigator. If disease progression is assessed by BICR, the investigator is allowed to unblind after disease progression according to the protocol-specified procedures. After unblinding, patients in the experimental arm, study drug should be discontinued. Patients in the control arm may be transferred to receive ABSK-011 plus BSC after assessment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Biomarker criteria
Required: FGF19 overexpression
Disease stage
Required: Stage BCLC STAGE B (INELIGIBLE FOR LOCAL OR RADICAL THERAPY, OR RELAPSE OR PROGRESSION OF DISEASE AFTER LOCAL THERAPY OR RADICAL THERAPY), BCLC STAGE C (BCLC)
BCLC stage B (ineligible for local or radical therapy, or relapse or progression of disease after local therapy or radical therapy) or C
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1/PD-L1 therapy — HCC
Have received at least one prior PD-(L)1 inhibitor approved as a single agent or in combination for the treatment of HCC
Must have received: multi-tyrosine kinase inhibitor — HCC
at least one mTKI approved for the treatment of HCC
Cannot have received: FGFR4 inhibitor
Previous treatment with selective FGFR4 inhibitors
Cannot have received: any anti-tumor therapy
Previous anti-tumor therapy is ≤ 4 weeks from randomization
Lab requirements
Blood counts
Adequate bone marrow function
Liver function
Child-Pugh class A
Child-Pugh class A. Adequate organ function and bone marrow function. Adequate control of blood pressure (BP) at screening.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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