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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
AST-201
DrugAST-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.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: AST-201Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose Limiting Toxicity (DLT)
Dose-limiting toxicity (DLT) is defined as any treatment-related Grade 3 or higher adverse event, or other clinically significant toxicity occurring during the first cycle (4 weeks), that meets the protocol-defined criteria for dose limitation, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version \[5.0\].
Time frame
4 weeksSecondary outcomes
1
Pharmacokinetics (PK): Cmax
Maximum Plasma Concentration (Cmax)
Time frame
Cycle 1, Days 1-2 (cycle is 28 days)2
Pharmacokinetics (PK): Tmax
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame
Cycle 1, Days 1-2 (cycle is 28 days)3
Pharmacokinetics (PK): AUC
Area Under the Curve (AUC)
Time frame
Cycle 1, Days 1-2 (cycle is 28 days)4
Pharmacokinetics (PK): Cl
Clearance Rate
Time frame
Cycle 1, Days 1-2 (cycle is 28 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aptamer Sciences, Inc.
Lead sponsor
CHA University
Collaborator
National Cancer Center, Korea
Collaborator
Samsung Medical Center
Collaborator
Severance Hospital
Collaborator
Source ClinicalTrials.gov