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

NCT06687941 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-03-27

No results posted yet for this 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.

Conditions

  • Neoplasms
  • Carcinoma, Hepatocellular
  • Carcinoma, Non-Small-Cell Lung
  • Liver Neoplasms

Interventions

DRUG

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.

Sponsors & Collaborators

  • CHA University

    collaborator OTHER

  • National Cancer Center, Korea

    collaborator OTHER_GOV

  • Samsung Medical Center

    collaborator OTHER

  • Severance Hospital

    collaborator OTHER

  • Aptamer Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • David Lee · Aptamer Sciences, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-11
Primary Completion
2027-12-31
Completion
2028-05-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06687941 on ClinicalTrials.gov