A phase I/IIA study of AGS-PSCA for castration-resistant prostate cancer.

ABSTRACT:

Background

This first-in-human phase I/IIA study was designed to evaluate the safety and pharmacokinetics (PKs) of AGS-PSCA a fully human monoclonal antibody directed to prostate stem cell antigen (PSCA) in progressive castration-resistant prostate cancer.

Patients and methods

Twenty-nine patients were administered infusions of AGS-PSCA (1-40 mg/kg) every 3 weeks for 12 weeks; 18 final patients received a 40-mg/kg loading dose followed by 20-mg/kg repeat doses. Primary end points were safety and PK. Immunogenicity, antitumor activity and circulating tumor cells were also evaluated.

Results

No drug-related serious adverse events were noted. Dose escalation stopped before reaching the maximum tolerated dose as target concentrations were achieved. Drug levels accumulated

SUBMITTER: Morris MJ 

PROVIDER: S-EPMC3457748 | biostudies-literature | 2012 Oct

REPOSITORIES: biostudies-literature