The phase II clinical trial is a multi-center, open-label study to evaluate the efficacy, safety and tolerability of HGS-ETR1 (mapatumumab), an agonistic human monoclonal antibody to TRAIL receptor 1, in patients with relapsed or refractory non-Hodgkin’s lymphoma.
The objectives of the study are to evaluate disease activity and tumor response to HGS-ETR1 in patients with advanced non-Hodgkin’s lymphoma, to evaluate the safety and tolerability of HGS-ETR1, and to determine plasma concentrations of HGS-ETR1 for use in a population pharmacokinetic analysis.
In November 2004, Human Genome Sciences announced the completion of enrollment and initial dosing of patients in a phase II study of HGS-ETR1 in advanced non-small cell lung cancer and in February 2005, announced the completion of enrollment and initial dosing in a phase II study in advanced colorectal cancer.
The three phase II studies of HGS-ETR1 initiated to date fit into a global clinical development program through which Human Genome Sciences is evaluating the novel, genomics-derived anticancer drug’s potential for use in the treatment of specific cancers.
The company expects to have the results of all three of the phase II studies available in 2005.