Evaluating AST-201 for 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
This study is testing a new treatment called AST-201 to see if it can help people with advanced solid tumors that have a specific marker called GPC3.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Aptamer Sciences, Inc. Industry-sponsored |
| Locations | 4 sites (Goyang-si, Gyeonggi-do and 3 other locations) |
| Trial ID | NCT06687941 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with GPC3-positive advanced recurrent solid tumors.
Not a fit: Patients with ischemic heart disease or those who have received anti-tumor treatment within the last four weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that express GPC3.
How similar studies have performed: While this approach is novel, preclinical studies have shown promising efficacy of AST-201 in GPC3-positive tumor models.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Goyang-si, Gyeonggi-do and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.