Actively Recruiting

Phase 1
Age: 19Years +
All Genders
NCT06687941

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

Led by Aptamer Sciences, Inc. · Updated on 2026-03-27

70

Participants Needed

4

Research Sites

163 weeks

Total Duration

On this page

Sponsors

A

Aptamer Sciences, Inc.

Lead Sponsor

C

CHA University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female aged 6519 years
  • Histologically and/or cytologically diagnosed with advanced recurrent solid tumor
  • GPC3-positive confirmed by immunohistochemistry (IHC) test
  • At least one measurable or evaluable lesion as per RECIST v1.1 or modified RECIST for hepatocellular carcinoma
  • ECOG performance status of 0 or 1
  • Life expectancy of at least 12 weeks
  • Adequate blood, liver, kidney, and heart/coagulation function
  • Child-Pugh Class A for hepatocellular carcinoma
Not Eligible

You will not qualify if you...

  • History of ischemic heart disease
  • Anti-tumor treatment within the last 4 weeks
  • Comorbid conditions such as uncontrolled hypertension or heart failure
  • Pregnant, potentially pregnant, or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea, 10408

Actively Recruiting

2

CHA Bundang Medical Center

Seongnam, South Korea, 13609

Actively Recruiting

3

Severance Hospital

Seoul, South Korea, 03722

Actively Recruiting

4

Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

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Research Team

A

Aptamer Sciences Inc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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