RTID-05. TRIAL IN PROGRESS: DOSE-FINDING STUDY AND EVALUATION OF [177LU]LU-DOTA-TATE IN COMBINATION WITH STANDARD OF CARE IN NEWLY DIAGNOSED GLIOBLASTOMA AND AS A SINGLE AGENT IN RECURRENT GLIOBLASTOMA

Abstract Patients with glioblastoma have a poor prognosis despite extensive efforts to develop new treatments. Standard of care for newly diagnosed patients is surgery followed by radiotherapy plus temozolomide. However, temozolomide only provides clinical benefit who glioblastomas methylated O(6)-methylguanine-DNA methyltransferase (MGMT) gene promotor. Disease recurrence inevitable and subsequent treatments outcomes due limited efficacy lack established therapeutic regimens. [68Ga]Ga-DOTA-TATE radioligand imaging agent that selectively binds somatostatin receptors (SSTRs) used positron emission tomography (PET) the molecular SSTR-positive neuroendocrine tumors. Glioblastoma tumoral PET scans shown moderate uptake [68Ga]Ga-DOTA-TATE. The therapy [177Lu]Lu-DOTA-TATE has same SSTR-targeted ligand demonstrated promising activity in pilot study Grade III/IV gliomas. This Phase 1b open-label dose-finding (NCT05109728) will determine recommended dose three different groups (newly MGMT promoter [group 1], unmethylated 2], recurrent disease 3]). All participants be scanned during screening and, each group, approximately 15 enrolled consecutive cohorts 3–6 participants. receive up 6 administrations (initial 150 mCi 3 provisional levels 250 mCi) using Bayesian Optimal Interval design. Group 1 every 4 weeks concomitant temozolomide, maintenance. 2 doses then as single agent. only, weeks. primary endpoint incidence limiting toxicity. Secondary endpoints include overall objective status (modified RANO criteria), progression free survival, survival safety.