A Study to Evaluate the Tolerability, Safety, and PK of AST-201 in Patients With GPC3-positive Advanced Solid Tumors

Launched by APTAMER SCIENCES, INC. · Nov 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AST-201 for patients with certain advanced solid tumors that are positive for a marker known as GPC3. The main goals of the study are to see how safe the treatment is, how well the body handles it, and to gather early information about how effective it might be against these types of tumors. This is the first time AST-201 is being tested in humans, and the trial is currently looking for participants.

To be eligible for this study, participants need to be at least 19 years old and have a confirmed diagnosis of an advanced solid tumor that has tested positive for GPC3. They should have at least one tumor that can be measured or evaluated. Participants must also be in reasonably good health, as determined by specific performance criteria. Those with certain heart conditions, recent cancer treatments, or other serious health issues may not be able to join. If you decide to participate, you will receive the treatment and be closely monitored for any side effects or changes in your condition, helping researchers understand how AST-201 works for people with these tumors.

Gender

ALL

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