FGF19 Overexpression Combination Unified Study in HCC-19

Phase 2

Recruiting

• Conditions: HCC - Hepatocellular Carcinoma
• Interventions: Drug: ABSK-011

• Registration Number: NCT06978933
• Lead Sponsor: RenJi Hospital

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

Study Timeline

• Study Start: 2025-04-30
• Status Verified: 2025-05
• Study First Submitted: 2025-05-11
• Study First Submitted QC: 2025-05-11
• Last Update Submitted: 2025-05-11
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-12
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABSK-011+ABSK043	ABSK-011	-

Primary Outcome Measures

Name	Time	Method
To evaluate the objective response rate of ABSK-011 plus ABSK043 in patients with previously treated unresectable or metastatic HCC harboring FGF19 overexpression	10 months	Objective response rate (ORR): complete response and partial response determined by the investigator according to RECIST v1.1 and to be confirmed

Trial Locations

Locations (1)

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, China