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Clinical Trials in South Korea / NCT06687941
Recruiting Phase 1

A Study to Evaluate the Tolerability, Safety, and PK of AST-201 in Patients With GPC3-positive Advanced Solid Tumors

NCT06687941 · tracked via the Priya Life Science South Korea tracker
Sponsor
Aptamer Sciences, Inc
Phase
Phase 1
Started
2025-03-11
Last updated
2026-03-27

Condition(s) studied

NeoplasmsCarcinoma, HepatocellularCarcinoma, Non-Small-Cell LungLiver Neoplasms

Investigational drug(s) / intervention(s)

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.

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria * 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 Criteria * 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

Primary outcome measure(s)

  • Dose Limiting Toxicity (DLT) — 4 weeks
    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 \[5.0\].

Trial sites (4)

FacilityCityRegionStatus
National Cancer Center, Korea Goyang-si Gyeonggi-do Recruiting
CHA Bundang Medical Center Seongnam South Korea Recruiting
Severance Hospital Seoul South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting

Other trials for the same condition

A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer Recruiting
A Study of JNJ-86974680 in Participants With Advanced Non-small Cell Lung Cancer Active, not recruiting
KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A) Recruiting
A Phase II Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Carbon Ion Radiotherapy With Atezolizumab and Bevacizumab Combination Therapy in Patients With Advanced Hepatocellular Carcinoma Recruiting
A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06687941 on ClinicalTrials.gov ↗ ← All trials in South Korea