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RecruitingPhase 2NCT06978933

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

Sponsor

RenJi Hospital

Enrollment

42 participants

Start Date

Apr 30, 2025

Study Type

INTERVENTIONAL

Conditions

HCC - Hepatocellular Carcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two targeted drugs — ABSK-011 and ABSK043 — for people with liver cancer (hepatocellular carcinoma, or HCC) whose tumors overexpress a protein called FGF19. These drugs target specific growth pathways that drive FGF19-positive liver cancer. **You may be eligible if...** - You have been diagnosed with liver cancer (HCC), confirmed by biopsy or imaging - Your cancer has progressed after at least one prior systemic treatment - Your tumor tests positive for FGF19 overexpression at a central laboratory - You are in good overall health (ECOG 0 or 1) - Your organ function is within acceptable ranges **You may NOT be eligible if...** - You have previously been treated with an FGFR4 or pan-FGFR inhibitor drug - You are allergic to the study medications - You have had hepatic encephalopathy (liver-related confusion) at any point - You have untreated brain metastases - You have another active cancer requiring treatment - You have HIV Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABSK-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

Locations(1)

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

Shanghai, China

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NCT06978933

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