This is a single-arm, non-randomized, open-label Phase 2 therapeutic study that will
assess the effects of adding BPM31510 onto a conventional treatment framework of RT and
concurrent TMZ chemotherapy for subjects with newly diagnosed glioblastoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04752813.
The study will start with a dose-confirmation phase to establish safety of BPM31510 in
combination with RT and TMZ. This phase will follow a standard 3+3 dose design with the
starting dose of BPM31510 at 110 mg/kg/week (wk), with 1 potential dose de-escalation to
66 mg/kg/wk in the event a DLT is experienced at the 110 mg/kg dose. Toxicity at this
dose level will be graded according to National Cancer Institute Common Terminology
Criteria for Adverse Events version 5 (CTCAE v5). Subjects will be monitored for DLTs
associated with combination therapy for 30 days (d) (± 5 d) after the end of RT (DLT
assessment period). Subjects will continue to be monitored for late radiation-related
DLTs during follow up, every 8 wk (± 2 wk) during the first 12 months (mo), and then
every 12 wk (± 2 wk) for a total of 5 years (y). Safety oversight will be provided by the
independent Data and Safety Monitoring Committee (DSMC). The DSMC will review and confirm
all DLT data, make recommendations for dose modifications, if necessary, and continue to
monitor safety throughout the study. The efficacy phase of the study will begin after the
recommended Phase 2 dose (RP2D) has been confirmed.
