|

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

RECRUITINGPhase 1Sponsored by Aptamer Sciences, Inc.
Actively Recruiting
PhasePhase 1
SponsorAptamer Sciences, Inc.
Started2025-03-11
Est. completion2027-12
Eligibility
Age19 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06687941

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

Age: 19 Years+Healthy volunteers accepted
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

Conditions8

CancerCarcinoma, HepatocellularCarcinoma, Non-Small-Cell LungLiver CancerLiver DiseaseLiver NeoplasmsLung CancerNeoplasms

Browse More Trials

Cancer trialsLung Cancer trialsLiver Disease trialsLiver Cancer trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.