Human Genome Sciences has completed the enrollment and initial dosing of patients in a phase II clinical trial of HGS-ETR1 in patients with advanced colorectal cancer.
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The phase II clinical trial is an open-label study to evaluate the efficacy, safety and tolerability of HGS-ETR1 (mapatumumab) in patients with relapsed or refractory colorectal cancer.
The primary objective of the study is to evaluate tumor response. The secondary objectives are to evaluate the safety and tolerability of HGS-ETR1, to determine plasma concentrations of HGS-ETR1 for use in a population pharmacokinetic analysis, and to evaluate other indicators of disease activity, including time to response, duration of response, and progression-free survival.
Dr David Stump, executive vice president of drug development, said, “We are pleased to have completed the enrollment of our phase II clinical trial of HGS-ETR1 in patients with colorectal cancer. We also have completed the enrollment of our phase II trial of HGS-ETR1 in non-small cell lung cancer, and we continue to enroll patients in our phase II trial in non-Hodgkin’s lymphoma.”
Human Genome Sciences expects to make the results of the three phase II studies available later this year, along with results from phase Ib studies of HGS-ETR1 in combination with chemotherapy.