FGF19 Overexpression Combination Unified Study in HCC-19

NCT ID: NCT06978933

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2027-12-31

Brief 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.

Detailed Description

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

Conditions

HCC - Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ABSK-011+ABSK043

Group Type: EXPERIMENTAL

ABSK-011

Intervention Type: 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

Interventions

ABSK-011

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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).

2. Progression of disease confirmed by imaging after receiving at least one line of systemic 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 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 or inadequately controlled central nervous system metastases that have not been effectively managed with treatment

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiang Xia, MD

Role: STUDY_CHAIR

Shanghai Jiao Tong University school of medicine affiliate Renji Hospital

Hao Feng, Ph.D.,MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University school of medicine affiliate Renji Hospital

Locations

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

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hao Feng, Ph.D.,MD

Role: CONTACT

surgeonfeng@live.com

+8615000901110

Facility Contacts

Hao Feng

Role: primary

surgeonfeng@live.com

+8615000901110

Other Identifiers

ABSK-011-2002-IIT

Identifier Type: -

Identifier Source: org_study_id