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New treatment option for HCC - Hepatocellular Carcinoma
Official title FGF19 Overexpression Combination Unified Study in HCC-19
ClinicalTrials.gov ID: NCT06978933
What this study is testing
What is ABSK-011?
ABSK-011 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hcc - hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with HCC confirmed by pathological histology or cytology, or meeting the clinical diagnostic criteria for HCC as the AASLD or Guidelines for...
- 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;
You likely can't join if
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.