An investigation of treatment with concurrent paxalisib and whole brain radiotherapy is underway in a phase 1 clinical trial. The FDA has granted fast track designation to the combination of paxalisib and radiation for the treatment of patients with brain metastases originating from a primary tumor. The trial aims to evaluate the safety and preliminary efficacy of the combination therapy in patients with solid tumor brain metastases or leptomeningeal metastases harboring PI3K pathway mutations. Data from 12 patients in the study have been reported, with all of them experiencing either a complete or partial response to the treatment. The recommended phase 2 dose of paxalisib has been set at 45 mg. The dose-expansion phase of the study will further evaluate the safety and efficacy of the combination therapy. The trial is expected to be completed by December 2025.
Fri, 07 Jul 2023 23:31:00 GMT | Targeted Oncology