A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor
Trial Parameters
Brief Summary
This is an open-label phase 1 study with an escalation part and an expansion part.
Eligibility Criteria
Inclusion Criteria: 1. Male or female, age 18 \~ 75 (include both ends, or other age range required by local regulations or IRB). 2. Escalation Part: Patients must have histological or cytological confirmed advanced solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists; and patients with advanced HCC must satisfy: 1. BCLC stage B or C and Child-Pugh score 5\~6 2. Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing Expansion Part: patients must have histological or cytological confirmed, BCLC stage B or C HCC, and have progressed on or intolerant to or have refused to receive or have no access to receive first line systemic therapy (by local guideline/regulation) and is unsuitable for other standard therapy(ies) (by local guideline/regulation) against HCC, and must satisfy: 1. Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing, and the result