A Study to Evaluate the Tolerability, Safety, and PK of AST-201 in Patients With GPC3-positive Advanced Solid Tumors
Trial Parameters
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Brief Summary
This is the first in human trial clinical study of AST-201 in patients with GPC3-positive advanced solid tumors. This study aims to evaluate the safety, tolerability, pharmacokinetic properties, and preliminary efficacy of AST-201 across various tumor types.
Eligibility Criteria
Inclusion Criteria * Male and female aged ≥19 years * Histologically and/or cytologically diagnosed as the advanced recurrent solid tumor * GPC3-positive confirmed by IHC test * At least 1 measurable or non-measurable but evaluable lesion as defined per RECIST v1.1 (modified RECIST for hepatocellular carcinoma) * ECOG performance status of 0 or 1 * Life expectancy at least 12 weeks * Adequate hematologic, hepatic, renal, and heart/coagulation function * Child-Pugh Class of A for HCC Exclusion Criteria * Subjects with ischemic heart disease * Subjects with anti-tumor treatment within 4 weeks * Subjects with comorbidities such as uncontrolled hypertension, heart failure, etc. * Pregnant or potentially pregnant and lactating woman