A Study to Evaluate the Tolerability, Safety, and PK of AST-201 in Patients With GPC3-positive Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorAptamer Sciences, Inc.
About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- AST-201
Treatment groups
70 Participants
are divided into 1 treatment groupLocations
4National Cancer Center, Korea10408, Goyang-siGyeonggi-do, South Korea
CHA Bundang Medical Center13609, Seongnam South Korea
Samsung Medical Center06351, Seoul South Korea
Severance Hospital03722, Seoul South Korea
Sponsors and collaborators
Aptamer Sciences, Inc.
Lead sponsor
CHA University
Collaborator
National Cancer Center, Korea
Collaborator
Samsung Medical Center
Collaborator
Severance Hospital
Collaborator
Source ClinicalTrials.gov