A Study to Evaluate the Tolerability, Safety, and PK of AST-201 in Patients With GPC3-positive Advanced Solid Tumors
NCT ID: NCT06687941
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
70 participants
INTERVENTIONAL
2025-03-11
2028-05-31
Brief Summary
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Detailed Description
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In Phase 1a, AST-201 will be administered in a dose escalating manner across cohorts of patients to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). In this dose-escalation phase, patients will receive AST-201 as a single agent, with safety, tolerability, and pharmacokinetic (PK) profiles assessed. In Phase 1b, patients will receive AST-201 at the RP2D across specific GPC3-positive tumor types to further explore safety and efficacy. This expansion phase focuses on assessing anti-tumor efficacy and overall safety in a broader patient population. Data collected from this study will support future clinical development of AST-201 in GPC3-positive advanced solid tumors.
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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AST-201
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 anti-tumor treatment within 4 weeks
* Subjects with comorbidities such as uncontrolled hypertension, heart failure, etc.
* Pregnant or potentially pregnant and lactating woman
19 Years
ALL
No
Sponsors
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CHA University
OTHER
National Cancer Center, Korea
OTHER_GOV
Samsung Medical Center
OTHER
Severance Hospital
OTHER
Aptamer Sciences, Inc.
INDUSTRY
Responsible Party
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Locations
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National Cancer Center, Korea
Gyeonggi-do, , South Korea
CHA Bundang Medical Center
Seongnam, , South Korea
Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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AST-201-01
Identifier Type: -
Identifier Source: org_study_id
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