FGF19 Overexpression Combination Unified Study in HCC-19
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ABSK-011.
- Who it may be relevant to
- Registry conditions: HCC - Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Interventions
- Drug ABSK-011
Drug: ABSK-011 RP2D according to the results of Phase I trial Other Names: • FGFR4 inhibitor Drug: ABSK043 RP2D according to the results of Phase I trial Other Names: • Oral PD-L1 inhibitor
Primary outcome measures
- To evaluate the objective response rate of ABSK-011 plus ABSK043 in patients with previously treated unresectable or metastatic HCC harboring FGF19 overexpression [Time frame: 10 months]
Eligibility criteria
Inclusion criteria
- 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;
Exclusion criteria
- 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 effectively managed with treatment
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai
Identifiers
NCT: NCT06978933 · ABSK-011-2002-IIT