Alpha Tau expands glioblastoma trial to 20 patients
- Alpha Tau Medical received FDA approval to expand its U.S. REGAIN trial of Alpha DaRT from 10 to up to 20 patients across three academic cancer centers.
- The updated protocol includes IDH-mutant grade 4 tumors, progression-free survival measurements and regular quality-of-life assessments.
- Alpha Tau will present additional REGAIN data on November 13, 2026, and believes the expanded study could support future regulatory submission requirements.
Alpha Tau Medical (NASDAQ:DRTS) received FDA authorization to expand its REGAIN brain cancer trial from 10 to 20 patients across three U.S. centers.
The expansion follows June 2026 FDA clearance to complete the original enrollment, after interim findings showed local disease control in all three initially treated patients.
“The FDA's approval to expand REGAIN represents an important milestone in our efforts to advance Alpha DaRT as a potential treatment option for patients with recurrent glioblastoma,” said Alpha Tau Chief Executive Officer Uzi Sofer.
The revised protocol includes IDH-mutant grade 4 tumors, progression-free survival, quality-of-life assessments and an additional interim analysis six months after July's fifth treatment.
Alpha Tau plans to present updated results on November 13 and believes expanded data could support regulatory submissions.
Alpha DaRT delivers radiation through implanted sources designed to release short-range alpha particles into tumors, while limiting exposure to surrounding healthy tissue.
Alpha Tau previously reported a 67% complete response rate among three REGAIN patients and expanded its oncology development through a June 2026 collaboration with Tolmar.
