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Also known as L-Boronophenylalanine intravenous administration
L-Boronophenylalanine administration · 1 trial · 1 indication
The primary objective is to assess the safety of accelerator-based neutron radiation using the nuBeam Suite, and explicitly, the nuBeam Treatment Delivery System (TDS) in delivering BNCT to treat cancer patients. Safety/toxicity of neutron radiation delivered by the nuBeam TDS will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 at one month after the last BNCT trial treatment.
| Arm | Type | Description |
|---|---|---|
| Single group - Dose escalation study | EXPERIMENTAL | Two BNCT trial treatments are scheduled to be administered to each study subject with a 4-week time interval between the 2 trial treatments (a range from 3.0 to 6.0 weeks is allowed for the interval). Neutron irradiations are given at the Helsinki University Hospital BNCT facility (Helsinki, Finland) using the nuBeam Suite. The nuBeam Treatment Delivery System within the nuBeam Suite delivers a neutron beam that has suitable energy and flux for clinical BNCT. The Instructions for Use/User Guide(s) containing the detailed instructions for using the system will be followed for the delivery of neutron irradiation for each BNCT trial treatment. The basic steps for the irradiation procedure are: 1. Neutron source preparation/calibration 2. CT imaging of the target region 3. Positioning of the study subject 4. Irradiation to the planned trial treatment dose 5. Close-out/Shutdown Each BNCT trial treatment will be carried out according to the trial treatment plan. |
| Name | Type | Description |
|---|---|---|
| L-Boronophenylalanine intravenous administration | DRUG | L-BPA will be complexed with fructose to form L-BPA-fructose (L-BPA-F) to increase solubility, and 400 mg/kg of L-BFA as complexed with fructose (L-BPA-F) will then be administered intravenously at a concentration of L-BPA 30 g/L over 2 hours before neutron irradiation. |
Inclusion Criteria: 1. The patient considered for the study has provided a written informed consent as approved by the EC prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. 2. ≥ 18 years of a...
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L-Boronophenylalanine is an investigational small molecule being studied for the treatment of Head and Neck Carcinoma. It is administered intravenously and is being evaluated in a Phase 1 clinical trial for this oncology indication.
L-Boronophenylalanine is used in Boron Neutron Capture Therapy (BNCT), a treatment approach for Head and Neck Carcinoma. The drug delivers boron to tumor cells, which are then irradiated with neutrons to destroy the cancer cells.
L-Boronophenylalanine is being developed by cbdMD, Inc., a company traded under the ticker YCBD. The drug is currently in Phase 1 clinical development for Head and Neck Carcinoma.
L-Boronophenylalanine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants.
L-Boronophenylalanine is being studied in one active Phase 1 trial, NCT07058116, titled 'Accelerator-based BNCT (Boron Neutron Capture Therapy) for Head and Neck Carcinoma.' This trial is recruiting 10 participants in Finland and is open to adults aged 18 and older.
Yes, L-Boronophenylalanine is also known as L-Boronophenylalanine intravenous administration. Both names refer to the same investigational drug being developed for Head and Neck Carcinoma.