FGF19 Overexpression Combination Unified Study in HCC-19

Last updated: May 11, 2025
Sponsor: RenJi Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Carcinoma

Treatment

ABSK-011

Clinical Study ID

NCT06978933
ABSK-011-2002-IIT
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with HCC confirmed by pathological histology or cytology, or meeting theclinical diagnostic criteria for HCC as the AASLD or Guidelines for the diagnosisand treatment of primary liver cancer (China).

  2. Progression of disease confirmed by imaging after receiving at least one line ofsystemic therapy

  3. The central laboratory test report for FGF19 overexpression positive.

  4. ECOG performance status of 0 or 1;

  5. Adequate organ and marrow function defined by study-specified laboratory tests;

Exclusion

Exclusion Criteria:

  1. Has received prior therapy with FGFR4 or pan-FGFR inhibitors;

  2. Hypersensitivity for any constituent of ABSK-011 or ABSK043;

  3. Past or current hepatic encephalopathy; patients with known untreated orinadequately controlled central nervous system metastases that have not beeneffectively managed with treatment

  4. have other malignant tumors that are currently in a progressive stage or requireeffective treatment

  5. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: ABSK-011
Phase: 2
Study Start date:
April 30, 2025
Estimated Completion Date:
December 31, 2027

Study Description

The patients that meet the Inclusion and Exclusion Criteria will treat with ABSK-011 RP2D and ABSK043 RP2D until the disease progression

Connect with a study center

  • Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai,
    China

    Active - Recruiting

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