Status:
RECRUITING
FGF19 Overexpression Combination Unified Study in HCC-19
Lead Sponsor:
RenJi Hospital
Conditions:
HCC - Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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) harbor...
Detailed Description
The patients that meet the Inclusion and Exclusion Criteria will treat with ABSK-011 RP2D and ABSK043 RP2D until the disease progression
Eligibility Criteria
Inclusion
- 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).
- Progression of disease confirmed by imaging after receiving at least one line of systemic therapy
- The central laboratory test report for FGF19 overexpression positive.
- ECOG performance status of 0 or 1;
- Adequate organ and marrow function defined by study-specified laboratory tests;
Exclusion
- Has received prior therapy with FGFR4 or pan-FGFR inhibitors;
- Hypersensitivity for any constituent of ABSK-011 or ABSK043;
- Past or current hepatic encephalopathy; patients with known untreated or inadequately controlled central nervous system metastases that have not been effectively managed with treatment
- have other malignant tumors that are currently in a progressive stage or require effective treatment
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
Key Trial Info
Start Date :
April 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06978933
Start Date
April 30 2025
End Date
December 31 2027
Last Update
May 18 2025
Active Locations (1)
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1
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China