Phase 1 Trial Testing Safety and Best Dose of BEY1107 with Temozolomide for Adults with Recurrent or Progressive Glioblastoma Multiforme

What this Trial Is About

Researchers are studying the safety and highest tolerated dose of BEY1107 combined with Temozolomide in adults who have recurrent or progressive glioblastoma multiforme GBM, a type of brain cancer that has not responded to standard treatments. This Phase 1 trial aims to find the best dose to use in future studies and assess how well the combination works. Participants must have measurable brain lesions and meet certain health criteria to join. Participants will receive BEY1107 taken twice daily by mouth continuously for 4 weeks alongside Temozolomide taken once daily by mouth for 5 days followed by a 23-day rest period. Each 4-week period is considered one treatment cycle. The trial is open-label, so all participants will receive this combination treatment while researchers monitor safety and dosing. During the study, participants will undergo various assessments including scans to measure tumor response, evaluations of side effects, and blood tests to understand drug levels in the body. Researchers will track outcomes such as the maximum tolerated dose, recommended dose for future trials, disease control rate, and progression-free survival over time. The total observation period may last up to 48 weeks or until disease progression. Safety and treatment effects will be closely monitored throughout.

A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)