Glioblastoma Treatment with Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients (GLORIA)
Status: active, not recruiting
Glioblastoma multiforme (GBM) is one of the deadliest and most aggressive forms of brain cancer. Patients with this devastating orphan disease are faced with extremely poor prognosis and a staggering 95% of them will not survive beyond 5 years. The standard of care – a combination treatment, including surgery, radiotherapy and chemotherapy – unfortunately is not curative. Moreover, not all patients benefit clinically from chemotherapy, which thus provides limited efficacy while increasing side-effect burden on patients. There is a huge unmet need for an effective approach to treat GBM that prevents tumor recurrence. Our approach is built on research and data suggesting that tumor microenvironment (TME) plays a critical role in how effective anti-cancer therapies are at fighting the disease.
GLORIA is Phase 1/2 study in glioblastoma (brain cancer) patients resistant to standard chemotherapy (unmethylated MGMT promoter) consisting of a dose-escalation part with NOX-A12 plus radiotherapy and three additional arms combining NOX-A12 with radiotherapy plus bevacizumab (VEGF inhibitor) or pembrolizumab (PD-1 inhibitor), or NOX-A12 plus radiotherapy in patients with complete tumor resection.
Therapies with NOX-A12 indicate promising and exciting efficacy, and potential for clinical benefit over standard of care.
1. Giordano (2022) ASCO Annual Meeting Presentation #2050 link
2. Giordano (2022) SNO Annual Meeting Poster Presentation #CTNI-67 link & TME Pharma Press Release 19 November 2022 link
3. TME Pharma Press Release 28 June 2023 link
RT = Radiotherapy; Beva = bevacizumab. Standard of care = RT + chemotherapy
Results in NOX-A12 + RT + Bevacizumab combination generated and reported to date2,3: