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NCT Number: NCT06978933

FGF19 Overexpression Combination Unified Study in HCC-19

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Shanghai, China

Location status: Recruiting

Location contact

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with HCC confirmed by pathological histology or cytology, or meeting the clinical diagnostic criteria for HCC as the AASLD or Guidelines for the diagnosis and treatment of primary liver cancer (China).
  • Progression of disease confirmed by imaging after receiving at least one line of systemic therapy
  • The central laboratory test report for FGF19 overexpression positive.
  • ECOG performance status of 0 or 1;
  • Adequate organ and marrow function defined by study-specified laboratory tests;

Exclusion criteria

  • Has received prior therapy with FGFR4 or pan-FGFR inhibitors;
  • Hypersensitivity for any constituent of ABSK-011 or ABSK043;
  • Past or current hepatic encephalopathy; patients with known untreated or inadequately controlled central nervous system metastases that have not been effectively managed with treatment
  • have other malignant tumors that are currently in a progressive stage or require effective treatment
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)

Treatment and study plan

ABSK-011

Drug

Drug: ABSK-011 RP2D according to the results of Phase I trial

Other Names:

  • FGFR4 inhibitor Drug: ABSK043 RP2D according to the results of Phase I trial

Other Names:

  • Oral PD-L1 inhibitor

Primary outcomes

  1. To evaluate the objective response rate of ABSK-011 plus ABSK043 in patients with previously treated unresectable or metastatic HCC harboring FGF19 overexpression

    Time frame: 10 months

    Objective response rate (ORR): complete response and partial response determined by the investigator according to RECIST v1.1 and to be confirmed

Study contacts

Contact information is provided by the study sponsor or research team.

Hao Feng, Ph.D.,MD

CONTACT

[email protected]

+8615000901110

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

A Prospective, Exploratory Study to Evaluate the Safety and Efficacy of the Combination of ABSK-011 and ABSK043 in Patients With Previously Treated Unresectable or Metastatic Hepatocellular Carcinoma With FGF19 Overexpression

Acronym: FOCUS-19

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 18, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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