Alpha Tau Announces FDA Approval to Expand Alpha DaRT® U.S. Recurrent Glioblastoma REGAIN Trial; New Trial Data to be Presented at SNO 2026 Annual Meeting
Alpha Tau Medical won FDA approval of an IDE supplement expanding its U.S. REGAIN trial of Alpha DaRT in recurrent glioblastoma from 10 to 20 patients. The updated protocol adds progression-free survival as a secondary endpoint, quality-of-life assessments, eligibility for IDH-mutant grade 4 tumors, and an interim analysis six months after the fifth patient's July 2026 treatment. An abstract from principal investigator Dr.
Key figures
- Drug Name
- Alpha DaRT
- Phase Of Trial
- REGAIN (Recurrent Glioblastoma Alpha DaRT Intratumoral Therapy) trial
- Study centers
- 3
- Enrollment expanded to
- 20
- Interim analysis timing
- six months after fifth patient's treatment (July 2026)
- Enrollment expanded from
- 10
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