Combination treatment for advanced liver cancer with FGF19 overexpression

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

This study is testing a new combination treatment for advanced liver cancer to see if it can help patients whose cancer has not responded to other therapies.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06978933 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and efficacy of a combination treatment using ABSK-011, a selective FGFR4 inhibitor, and ABSK043, a PD-1/PD-L1 inhibitor, in patients with unresectable or metastatic hepatocellular carcinoma (HCC) that overexpresses FGF19. Patients who have previously undergone systemic therapy will receive these treatments until disease progression. The study aims to determine the effectiveness of this combination therapy in improving patient outcomes compared to existing treatments.

Who should consider this trial

Good fit: Ideal candidates include patients with confirmed HCC who have experienced disease progression after at least one line of systemic therapy and have FGF19 overexpression.

Not a fit: Patients who have previously received FGFR4 or pan-FGFR inhibitors or those with untreated central nervous system metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced liver cancer that is difficult to treat.

How similar studies have performed: Other studies have shown promising results with similar targeted therapies, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. 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).
2. Progression of disease confirmed by imaging after receiving at least one line of systemic therapy
3. The central laboratory test report for FGF19 overexpression positive.
4. ECOG performance status of 0 or 1;
5. Adequate organ and marrow function defined by study-specified laboratory tests;

Exclusion Criteria:

1. Has received prior therapy with FGFR4 or pan-FGFR inhibitors;
2. Hypersensitivity for any constituent of ABSK-011 or ABSK043;
3. Past or current hepatic encephalopathy; patients with known untreated or inadequately controlled central nervous system metastases that have not been effectively managed with treatment
4. have other malignant tumors that are currently in a progressive stage or require effective treatment
5. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)

Where this trial is running

Shanghai

• Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Hao Feng, Ph.D.,MD — Shanghai Jiao Tong University school of medicine affiliate Renji Hospital
• Study coordinator: Hao Feng, Ph.D.,MD

Conditions HCC - Hepatocellular Carcinoma