NCT06687941RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 5 Nov 2024
- Start date
- 11 Mar 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Aptamer Sciences, Inc.
- NCT number
- NCT06687941
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 70
- From 11 Mar 2025 to the primary completion date, Dec 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subjects with ischemic heart disease
- Subjects with comorbidities such as uncontrolled hypertension, heart failure, etc.
Other
- Subjects with anti-tumor treatment within 4 weeks
- Pregnant or potentially pregnant and lactating woman
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center - Korea Coordinator of this site? Confirm its status | Goyang-si | South Korea | Recruiting |
| CHA Bundang Medical Center Coordinator of this site? Confirm its status | Seongnam | South Korea | Recruiting |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.