A Study to Evaluate the Tolerability, Safety, and PK of AST-201 in Patients With GPC3-positive Advanced Solid Tumors
A Multi-center, Open-label, Dose Escalation and Expansion, Phase 1 Study to Evaluate the Tolerability, Safety and Pharmacokinetics of AST-201 in Patients With GPC3-positive Advanced Solid Tumors
Aptamer Sciences, Inc.
70 participants
Mar 11, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria4
- 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
Interventions
AST-201 is administered intravenously on Days 1, 8, and 15 of each 28-day cycle, followed by a one-week rest period. Dosing is repeated until DLT or disease progression is occurred.
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT06687941