Alpha Tau Receives FDA Clearance to Complete Enrollment in REGAIN Recurrent Glioblastoma Trial and Add Two U.S. Clinical Sites; Early Interim Results Showed 100% Local Disease Control
The FDA cleared Alpha Tau to resume enrollment in its REGAIN trial for recurrent glioblastoma, allowing recruitment of the final seven patients. This decision follows a pre-specified interim safety report from the first three patients, which showed 100% local disease control and a 67% complete response rate with only one manageable grade 3 adverse event. The company also added two new U.S.
Key figures
- Drug Name
- Alpha DaRT
- Phase Of Trial
- feasibility/safety (single-arm)
- Total trial size
- 10
- Grade 3 sae count
- 1
- New us sites added
- 2
- Complete response rate
- 67%
- Patients treated interim
- 3
- Local disease control rate
- 100%
- Remaining patients to enroll
- 7
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