Actively Recruiting
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
Led by Aptamer Sciences, Inc. · Updated on 2026-03-27
70
Participants Needed
4
Research Sites
21 weeks
Total Duration
On this page
Sponsors
A
Aptamer Sciences, Inc.
Lead Sponsor
C
CHA University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating AST-201, a new aptamer drug conjugate (ApDC), in patients with GPC3-positive advanced solid tumors. This Phase 1 clinical study aims to assess the safety, tolerability, pharmacokinetics, and early signs of effectiveness of AST-201 across various tumor types, including hepatocellular carcinoma and non-small-cell lung carcinoma. The study is the first to test AST-201 in humans and is sponsored by Aptamer Sciences, Inc. The study has two parts: Phase 1a involves gradually increasing doses of AST-201 given intravenously on Days 1, 8, and 15 of each 28-day cycle to find the highest safe dose and the recommended dose for further studies. In Phase 1b, patients receive the recommended dose to further evaluate safety and anti-tumor effects. Treatment continues until participants experience dose-limiting toxicity or disease progression. Participants will have regular assessments including safety monitoring, blood tests for drug levels, and tumor evaluations using RECIST criteria. The main outcome measured is the occurrence of dose-limiting toxicities within 4 weeks. Secondary outcomes include various pharmacokinetic parameters and tumor response rates assessed every 28 days for up to 6 months. The study involves ongoing safety follow-up and aims to support future development of AST-201 in this patient population.
CONDITIONS
Brief Title
A Study to Evaluate the Tolerability, Safety, and PK of AST-201 in Patients With GPC3-positive Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female aged 19 years or older
- Histologically and/or cytologically diagnosed advanced recurrent solid tumor
- GPC3-positive confirmed by immunohistochemistry (IHC) test
- At least one measurable or evaluable lesion as defined by RECIST v1.1 or modified RECIST for hepatocellular carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate hematologic, hepatic, renal, and heart/coagulation function
- Child-Pugh Class A for hepatocellular carcinoma (HCC) patients
You will not qualify if you...
- History of ischemic heart disease
- Anti-tumor treatment received within 4 weeks prior to enrollment
- Comorbidities such as uncontrolled hypertension or heart failure
- Pregnant, potentially pregnant, or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until dose limiting toxicity or disease progression
Participants receive AST-201 intravenously on Days 1, 8, and 15 of each 28-day cycle, followed by a one-week rest period. This dosing is repeated until dose limiting toxicity or disease progression occurs.
3 visits per 28-day cycle (in-person)
Trial Site Locations
Total: 4 locations
1
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea, 10408
Actively Recruiting
2
CHA Bundang Medical Center
Seongnam, South Korea, 13609
Actively Recruiting
3
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
4
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
A
Aptamer Sciences Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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