NCT06978933RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 18 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 11 May 2025
- Start date
- 30 Apr 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- RenJi Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06978933
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 42
- From 30 Apr 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received prior therapy with FGFR4 or pan-FGFR inhibitors;
Other illness
- Hypersensitivity for any constituent of ABSK-011 or ABSK043;
- 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)
Other
- Past or current hepatic encephalopathy; patients with known untreated or inadequately controlled central nervous system metastases that have not been effectively managed with treatment
Who the study is looking for
- 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;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.