Human Genome Sciences has announced that the results of two Phase I clinical
trials demonstrate that HGS-ETR2 is well-tolerated and can be administered safely
and repetitively in patients with advanced solid tumors, and support further
evaluation in Phase II trials. Stable disease was observed in a number of patients
in each of the studies.
The trials were open-label, dose-escalation, two-center studies. Patients participating in the studies previously received multiple cancer treatment regimens, including chemotherapy, immunotherapy, radiotherapy, hormone therapy and/or surgery. The patients were enrolled into six cohorts and received HGS-ETR2 administered intravenously on a 21-day schedule, with dosing to disease progression in the absence of dose-limiting toxicities.
Results demonstrated that HGS-ETR2 was well-tolerated, with minimal toxicity at doses up to 10 mg/kg, and could safely be administered intravenously every 21 days. Dose-limiting toxicity (DLT) was defined at a dose of 20 mg/kg. No DLTs occurred at the 10-mg/kg dose level. The pharmacokinetics of HGS-ETR2 were found to be linear across a 200-fold dose range. Stable disease was observed in 11 of these heavily pre-treated patients, including patients with refractory sarcoma.