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FGF19 Overexpression Combination Unified Study in HCC-19

NCT06978933 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-05-18

No results posted yet for this study

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.

Conditions

  • HCC - Hepatocellular Carcinoma

Interventions

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

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Qiang Xia, MD · Shanghai Jiao Tong University school of medicine affiliate Renji Hospital

  • Hao Feng, Ph.D.,MD · Shanghai Jiao Tong University school of medicine affiliate Renji Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06978933 on ClinicalTrials.gov