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B10 L-BPA · 1 trial · 2 indications
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...
B10 L-BPA is an investigational small molecule being studied for the treatment of meningioma, a type of brain tumor. It is used in boron neutron capture therapy (BNCT), a technique that combines a boron-containing compound with neutron irradiation to target cancer cells. The drug is currently in Phase 1 clinical development.
B10 L-BPA is a boron-containing compound used in boron neutron capture therapy (BNCT). It is designed to deliver boron-10 to tumor cells, which then capture neutrons and produce a lethal effect on the cancer cells. The specific molecular target is not disclosed in the available information.
B10 L-BPA is being developed by Heron Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol HRTX. The company is conducting clinical research on this investigational drug for the treatment of meningioma.
B10 L-BPA is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy. The Phase 1 study has been completed.
B10 L-BPA has one completed clinical trial, identified as NCT06668987, titled 'A Study of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Recurrent Meningioma.' This Phase 1 study enrolled 10 participants in Taiwan and was an uncontrolled, non-randomized trial.
B10 L-BPA is not the same as boron neutron capture therapy (BNCT); rather, it is the boron-containing drug used within BNCT. BNCT is the overall treatment approach that combines B10 L-BPA with neutron irradiation to target tumor cells. The drug is being studied specifically for recurrent meningioma.