This is a Phase 2 study to evaluate the efficacy and safety of BB102, a highly selective and potent FGFR4 inhibitor, as monotherapy in subjects with advanced or unresectable FGF19-overexpressing hepatocellular carcinoma. This study has two phase: dose escalation phase and expansion phase.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Oral BB102 Tablets in two dosage
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Objective response rate (ORR)
Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
Time frame: From enrollment to the end of treatment assessed up to 12 months
Disease control rate (DCR)
Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
Time frame: From enrollment to the end of treatment assessed up to 12 months
Duration of response (DOR)
Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
Time frame: From enrollment to the end of treatment assessed up to 12 months
Progression-free survival (PFS)
Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
Time frame: From enrollment to the end of treatment assessed up to 12 months
Time-To-Progression (TTP)
Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
Time frame: From enrollment to the end of treatment assessed up to 12 months
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
AEs and SAEs will be characterized by type, seriousness, relationship to study treatment, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0) and timing.
Time frame: From enrollment to the end of treatment assessed up to 12 months
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