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Also known as B10 L-BPA Injection
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 developed by Heron Therapeutics, Inc. (ticker HRTX) as an agent for boron neutron capture therapy (BNCT). It is being studied in oncology, specifically for the treatment of meningioma. It has completed a Phase 1 clinical trial and is not approved for commercial use.
B10 L-BPA is used as a boron delivery agent in boron neutron capture therapy (BNCT) for patients with recurrent meningioma. In the completed Phase 1 study, it was administered as part of the BNCT procedure in Taiwan. It remains an investigational therapy and is not approved for routine clinical use.
B10 L-BPA is being developed by Heron Therapeutics, Inc., which trades on the Nasdaq under the ticker symbol HRTX. The company is the sponsor of the clinical program evaluating the agent in boron neutron capture therapy for meningioma.
B10 L-BPA has completed a Phase 1 clinical trial. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The Phase 1 study enrolled 10 participants and has been completed, with no active trials currently listed.
B10 L-BPA has been evaluated in one clinical trial, NCT06668987, titled "A Study of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Recurrent Meningioma." The Phase 1 study enrolled 10 participants in Taiwan, included patients aged 20 years and older of all sexes, and has been completed.
Yes, B10 L-BPA Injection is an alternative name for B10 L-BPA. Both names refer to the same investigational small molecule developed by Heron Therapeutics, Inc. (HRTX) for use in boron neutron capture therapy for recurrent meningioma. Searches for either name refer to the same asset.