NCT06978933

FGF19 Overexpression Combination Unified Study in HCC-19

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2025-04-30
• Primary completion: 2026-12-01
• Completion: 2027-12-31
• First posted: 2025-05-18
• Last updated: 2025-05-18

Locations

1 site across 1 country: China