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news.Infinity Pharmaceuticals, a cancer drug discovery and development company, has initiated a Phase I clinical trial of its oral Hedgehog signaling pathway inhibitor, IPI-926, in patients with advanced or metastatic solid tumors.
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The Phase I trial is an open-label, dose-escalation study evaluating IPI-926 in approximately 30 to 50 patients with advanced or metastatic solid tumors. The primary objectives of the study are to evaluate the safety, tolerability, and pharmacokinetics of IPI-926, and to determine a recommended dose and schedule for subsequent studies.
Additionally, Infinity will evaluate potential anti-tumor activity of IPI-926, and examine pharmacodynamic markers of its biological activity. In this trial, IPI-926 is being administered daily.
IPI-926 is a novel, proprietary inhibitor of the Hedgehog signaling pathway. It is a derivative of the natural product cyclopamine that binds to and inhibits a key regulator of this pathway, the smoothened receptor.
Julian Adams, chief scientific officer at Infinity, said: “The initiation of this trial marks an important milestone for Infinity. IPI-926 has shown significant oral bioavailability, a long half-life, and excellent in vivo activity in preclinical models. We are enthusiastic about the potential of IPI-926 and look forward to pursuing additional studies across a breadth of tumor types in the future.”