The primary objectives of the Phase I open-label, dose-escalation study are to evaluate the safety and tolerability of HGS1029 as monotherapy in patients with advanced solid tumors, and to select a recommended dose for Phase II studies.
Secondary objectives include documenting possible anti-tumor activity and determining HGS1029’s pharmacokinetic profile. HGS1029 will be administered as a 15-minute infusion once weekly for three consecutive weeks followed by a week off. Up to 40 patients will be treated in the study, with 15-20 patients treated in the dose-escalation phase.
Gilles Gallant, vice president of clinical research for oncology at Human Genome Sciences, said: “We are pleased to initiate this first human study of HGS1029, and we look forward to studying our IAP inhibitors both alone and in combination with other anti-cancer agents, including our Trail receptor antibodies.”