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A Study to Evaluate the Tolerability, Safety, and PK of AST-201 in Patients With GPC3-positive Advanced Solid Tumors
Sponsor: Aptamer Sciences, Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2025-03-11
Completion Date
2028-05
Last Updated
2026-03-27
Healthy Volunteers
No
Interventions
AST-201
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)
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea
CHA Bundang Medical Center
Seongnam, South Korea
Severance Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea