Actively Recruiting
FGF19 Overexpression Combination Unified Study in HCC-19
Led by RenJi Hospital · Updated on 2025-05-18
42
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
FGF19 Overexpression Combination Unified Study in HCC-19
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with hepatocellular carcinoma confirmed by pathology, cytology, or clinical diagnostic criteria
- Disease progression confirmed by imaging after at least one line of systemic therapy
- Positive test for FGF19 overexpression from a central laboratory
- ECOG performance status of 0 or 1
- Adequate organ and marrow function based on study-specific lab tests
You will not qualify if you...
- Prior treatment with FGFR4 or pan-FGFR inhibitors
- Hypersensitivity to any component of ABSK-011 or ABSK043
- Past or current hepatic encephalopathy or untreated/uncontrolled central nervous system metastases
- Presence of other progressive malignant tumors requiring active treatment
- Known history of HIV infection (HIV 1/2 antibodies)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China
Actively Recruiting
Research Team
H
Hao Feng, Ph.D.,MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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