Clinical trial NCT06978933: FGF19 Overexpression Combination Unified Study in HCC-19
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: HCC - Hepatocellular Carcinoma
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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) 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.

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 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)

Primary outcomes:
measure: To evaluate the objective response rate of ABSK-011 plus ABSK043 in patients with previously treated unresectable or metastatic HCC harboring FGF19 overexpression
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Study officials:
affiliation: Shanghai Jiao Tong University school of medicine affiliate Renji Hospital
name: Qiang Xia, MD
role: STUDY_CHAIR
affiliation: Shanghai Jiao Tong University school of medicine affiliate Renji Hospital
name: Hao Feng, Ph.D.,MD
role: PRINCIPAL_INVESTIGATOR
References: