Full TitleA Phase 1/1b First-In-Human, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549 Monotherapy and in Combination with Nivolumab in Subjects with Advanced Solid Tumors
IPI-549 is a drug that inhibits the activity of an enzyme called PI3 kinase. Laboratory studies have shown that inhibiting PI3 kinase may activate immune cells to slow or stop cancer growth. Doctors are interested in combining IPI-549 with immunotherapy drugs like nivolumab, which lifts the brakes on the immune response, thereby enhancing the immune response against cancer even further.
In this part of this study, researchers want to find the highest dose of IPI-549 that can be given safely in patients with advanced solid tumors. They also want to learn what doses of IPI-549 are safe to combine with nivolumab. IPI-549 is a capsule that is taken orally (by mouth). Nivolumab is given by outpatient intravenous infusion (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have an advanced or metastatic solid tumor that has stopped responding to standard therapy or for which no standard therapy is available.
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is for patients age 18 and older.