Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06668987 | A Study of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Recurrent Meningioma | PHASE1 | COMPLETED | 10 | — | — | Oct 14, 2024 | Feb 23, 2026 | May 11, 2026 | 1 | Taiwan |
Safety will be assessed by monitoring the frequency and severity of treatment-emergent adverse events (TEAEs), including serious adverse events and those causing permanent discontinuation of therapy as per protocol. Additionally, safety evaluations will track changes in laboratory test results, vital signs, physical examination findings, and the Eastern Cooperative Oncology Group (ECOG) performance status. Efficacy of BNCT with B10 L-BPA for treating recurrent meningioma will be assessed by the percentage of subjects achieving complete response (CR) and partial response (PR). Tumor response and progression will be evaluated according to RECIST 1.1 criteria, using high-resolution CT or MRI, which defines four response categories: CR, PR, stable disease (SD), and progressive disease (PD). In addition, local control will be evaluated as a separate endpoint.
| Arm | Type | Description |
|---|---|---|
| BNCT, recurrent meningioma. | EXPERIMENTAL | Single arm treated by BNCT only |
| Name | Type | Description |
|---|---|---|
| B10 L-BPA Injection | DRUG | The investigational product is B10 L-BPA Injection, is a boron-containing compound in which 10B replaces a position on L-phenylalanine at the para position with dihydroxyboron. |
Inclusion Criteria: 1. Age of 20 years and older. 2. Patients with recurrent intracranial meningioma confirmed by medical imaging, classified as WHO Grade 1 to 3 according to the World Health Organization grading system for meningioma, are eligible for inclusion. 3. Prior surgery, radiation therapy...