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news.Phase I trial results have demonstrated the safety and tolerability of Human Genome Sciences' HGS-ETR1 in patients with advanced solid tumors, supporting further evaluation of HGS-ETR1 in phase II clinical trials, both as a single agent and in combination with chemotherapy.
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The primary purpose of the phase I clinical trial was to determine the safety, maximum tolerated dose, dose-limiting toxicities, and pharmacokinetics of HGS-ETR1 in patients with relapsed or refractory advanced tumors.
Results of the study demonstrate that HGS-ETR1 can be administered safely and repetitively to patients with advanced solid malignancies at doses up to and including 10mg/kg intravenously every 14 or 28 days.
Stable disease was observed in ten of the patients after two courses of HGS- ETR1. One subject with cancer of the appendix continued on study with stable disease after 16 courses of HGS-ETR1 at a dose of 10.0mg/kg administered every 14 days. Accrual in the trial continues.
Human Genome Sciences also announced that, in an ongoing phase I trial of HGS-ETR2, interim results have shown this treatment to be well tolerated, with minimal toxicities. Stable disease has been observed in five patients and the trial continues to enroll patients at higher dose levels.