The multi-center, Phase I study of oral IPI-493 is designed as a dose-escalation trial in patients with advanced solid tumors. The primary objectives of the study are to assess safety and tolerability and to identify a treatment regimen for subsequent studies of IPI-493.
Anti-tumor activity of IPI-493 will be measured using computed tomography imaging using response evaluation criteria in solid tumors, as well as disease specific markers. Pharmacokinetics parameters, biologic activity, and effects of IPI-493 on pharmacodynamic markers of biological activity will also be assessed.
In addition to starting the Phase I trial of IPI-493, Infinity continues to advance its anti-chaperone program, which includes a planned Phase registration study of IPI-504 in patients with refractory gastrointestinal stromal tumors.
IPI-504 is also being evaluated in the Phase II portion of a Phase I/ II trial in patients with non-small cell lung cancer and a Phase Ib trial in combination with docetaxel. IPI-493 and IPI-504 are being jointly developed by Infinity and AstraZeneca/MedImmune.
Julian Adams, chief scientific officer of Infinity, said: “The initiation of clinical development for IPI-493 augments our industry-leading portfolio of anti-chaperone agents and marks the second proprietary drug candidate discovered by Infinity scientists to enter human clinical trials.”