RecruitingPhase 1NCT06687941

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

A Multi-center, Open-label, Dose Escalation and Expansion, Phase 1 Study to Evaluate the Tolerability, Safety and Pharmacokinetics of AST-201 in Patients With GPC3-positive Advanced Solid Tumors


Sponsor

Aptamer Sciences, Inc.

Enrollment

70 participants

Start Date

Mar 11, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing the safety and dosing of a new drug called AST-201 in patients with advanced solid tumors that test positive for a protein called GPC3 — which is found in certain cancers, including liver cancer. **You may be eligible if...** - You are 19 years or older - You have been diagnosed with an advanced solid tumor that has not responded to standard treatments - Your tumor tests positive for GPC3 (a protein marker) on biopsy - You have at least one measurable or evaluable tumor site - You are physically functional (ECOG 0–1) and expected to live at least 12 weeks - Your heart, kidney, liver, and blood function are within acceptable ranges - If you have liver cancer (HCC), you have Child-Pugh Class A liver function **You may NOT be eligible if...** - You have ischemic heart disease - You received anti-cancer treatment in the past 4 weeks - You have uncontrolled high blood pressure or heart failure - You are pregnant, potentially pregnant, or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAST-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.


Locations(4)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

CHA Bundang Medical Center

Seongnam, South Korea

Severance Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT06687941


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