Evaluating AST-201 for GPC3-positive advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study is the first in humans to evaluate AST-201, a novel aptamer-drug conjugate, in patients with GPC3-positive advanced solid tumors. The study is divided into two phases: Phase 1a focuses on determining the maximum tolerated dose and pharmacokinetic properties of AST-201, while Phase 1b assesses its safety and preliminary efficacy across specific tumor types. Patients will receive AST-201 as a single agent, and the study aims to gather data to support future clinical development of this treatment for GPC3-positive tumors.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Aptamer Sciences Inc.
• Email: kjkim@aptsci.com
• Phone: +82-70-5067-4275

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.