Debio 0123 + Temozolomide for Glioblastoma

This trial aims to determine the optimal dosage and assess the safety of a new drug, Debio 0123, when combined with the chemotherapy drug temozolomide (TMZ) and sometimes with radiation therapy. The study targets glioblastoma (GBM), a fast-growing brain tumor, and will compare the effectiveness of the new treatment against the current standard treatment. Individuals whose GBM has returned or worsened after standard treatment might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants the chance to be among the first to receive this new treatment.

The trial protocol does not specify if you need to stop taking your current medications. However, participants with seizures must have their condition controlled on a stable regimen of anti-epileptic drugs, and those on corticosteroids must be on a stable or decreasing dose. It's best to discuss your specific medications with the trial team.

Research has shown that Debio 0123, when combined with temozolomide, is generally safe for most patients at certain doses, meaning serious side effects were uncommon at these levels. However, combining Debio 0123 with both temozolomide and radiotherapy led to safety issues for some participants, causing one part of the study to stop due to safety concerns.

Researchers are excited about Debio 0123 in combination with temozolomide for glioblastoma because it offers a novel approach compared to standard treatments like surgery, radiation, and chemotherapy with temozolomide alone. Debio 0123 is designed to enhance the effectiveness of temozolomide by potentially making cancer cells more sensitive to treatment. This combination could improve outcomes by targeting the cancer more precisely and effectively. Moreover, the addition of radiotherapy in some treatment arms might work synergistically with Debio 0123 and temozolomide, providing a multifaceted attack on the tumor. This innovative approach holds promise for improving patient survival and quality of life.

Research has shown that Debio 0123 could be a promising treatment for glioblastoma, a type of brain cancer. In animal studies, Debio 0123 effectively worked with temozolomide, a common chemotherapy drug, to shrink tumors. Participants in this trial will receive Debio 0123 combined with temozolomide, with some also receiving radiotherapy. Debio 0123 is a selective WEE1 inhibitor, targeting a specific protein that helps cancer cells survive. Lab tests demonstrated that using Debio 0123 with radiation increased cancer cell death, enhancing the treatment's effectiveness. These early results suggest that Debio 0123 might improve current treatments for glioblastoma.¹²⁶⁷⁸