A Study of NST-628 in Recurrent Grade 4 Glioma

The study includes two components, a Phase 0 design and an expansion Phase 1 design. Participants in the Phase 0 component will receive multiple doses of NST-628 orally prior to their planned surgical resection. Blood, CSF, and tumor tissue will be collected intraoperatively to assess PK and PD endpoints. Participants whose tumors express a positive PD response in gadolinium non-enhancing tissue will be eligible to enroll into the Phase 1 component. Participants in the Phase 1 component will receive NST-628 orally every other day in 28-day cycles. Participants will receive NST-628 as long as the drug is tolerated and the investigator believes the participant may be obtaining benefit. Study treatment will continue until disease progression, unacceptable toxicity, death, withdrawal of consent, loss to follow up, or study termination by the Sponsor. Disease progression will be monitored through MRI scans per standard of care and will be assessed using RANO 2.0 criteria. Participants who terminate study treatment will be contacted for survival data collection. The end of the study is 12 months after the last participant's last visit.