NCT06687941 A Study to Evaluate the Tolerability, Safety, and PK of AST-201 in Patients With GPC3-positive Advanced Solid Tumors
| NCT ID | NCT06687941 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Aptamer Sciences, Inc. |
| Condition | Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-03-11 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 70 participants in total. It began in 2025-03-11 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
David Lee
STUDY DIRECTOR
Aptamer Sciences, Inc.
Frequently Asked Questions
Who can join the NCT06687941 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06687941 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06687941 currently recruiting?
Yes, NCT06687941 is actively recruiting participants. Contact the research team at kjkim@aptsci.com for enrollment information.
Where is the NCT06687941 trial being conducted?
This trial is being conducted at Goyang-si, South Korea, Seongnam, South Korea, Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT06687941 clinical trial?
NCT06687941 is sponsored by Aptamer Sciences, Inc.. The principal investigator is David Lee at Aptamer Sciences, Inc.. The trial plans to enroll 70 participants.