Phase 12 Study of Debio 0123 with Temozolomide in Adults With Recurrent or Progressive Glioblastoma and With Temozolomide Plus Radiotherapy in Newly Diagnosed Glioblastoma

What this Trial Is About

Researchers are studying the safety, tolerability, and effectiveness of Debio 0123 combined with temozolomide TMZ, with or without radiotherapy RT, in adults with glioblastoma GBM and grade III astrocytoma. This Phase 12 trial aims to find dose-limiting toxicities and the recommended dose for Debio 0123 in combination with TMZ. The study also compares this combination to the standard of care in participants with recurrent, progressive, or newly diagnosed glioblastoma. Participants receive intermittent escalating doses of Debio 0123 capsules along with TMZ capsules in 28-day cycles for up to two years. In some study arms, radiotherapy is given concurrently for about six weeks. Phase 1 includes dose escalation and dose expansion to determine the best dose. Phase 2 tests the recommended doses efficacy compared to standard treatment. One arm involving Debio 0123 with TMZ and radiotherapy has been permanently halted due to safety concerns. During the study, participants undergo regular assessments including brain MRI scans to measure tumor response using RANO criteria, blood tests, vital sign monitoring, electrocardiograms, echocardiograms, and performance status evaluations. Researchers monitor adverse events, pharmacokinetics of Debio 0123 and TMZ, and overall survival. The study may last up to approximately 66 months, with safety follow-up continuing for 30 days after treatment ends.

A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma