About this trial
This is an open-label phase 1 study with an escalation part and an expansion part.
Eligibility criteria
Qualifiers
Male or female, age 18 ~ 75 (include both ends, or other age range required by local regulations or IRB).
BCLC stage B or C and Child-Pugh score 5~6
Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing
Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing, and the result must be positive
Disqualifiers
Known allergy or hypersensitivity to any component of the investigational drug product.
Previous treatment with FGFR4 or pan-FGFR pathway inhibitors (pan-FGFR inhibitors should be confirmed with the sponsor).
Has a known second primary malignancy required active treatment.
Has a known active central nervous system (CNS) metastases (if stable disease after treatment, free from or daily dexamethasone <10 mg or other equivalent glucocorticoids can be enrolled).
Trial design
Treatments tested in this trial
- ABSK-011