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MeningiomaPhase 1/2NCT06668987

A Study of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Recurrent Meningioma

A Phase 1/2 study testing B10 L-BPA Injection in people with Meningioma and Boron Neutron Capture Therapy, run by Heron Neutron Medical Corp. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This Phase I/II study, titled 'A Study to Evaluate the Safety and Efficacy of Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA as a Boron Carrier in Recurrent Meningioma', aims to assess the efficacy of B10 L-BPA with BNCT in patients with recurrent meningioma. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Meningioma, Boron Neutron Capture Therapy
What is being tested?
B10 L-BPA Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteTaiwan
Study dates
14 Oct 2024to 23 Feb 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age of 20 years and older.
  • 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.
  • Prior surgery, radiation therapy, radiosurgery, proton therapy, heavy ion therapy, or boron neutron capture therapy for the disease.
  • There must be a time interval ≥ 3 months between prior radiation therapy and the scheduled BNCT.
  • There must be a time interval ≥ 1 month between receipt of antitumor drugs and the scheduled BNCT.
  • Measurable disease by magnetic resonance imaging (MRI) and/or computed tomography (CT) scan and ≤ 12 cm in the longest dimension.
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  • At least one measurable lesion that can be assessed by RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Score ≤ 2.
  • Life expectancy ≥ 3 months in the opinion of the investigator.
  • Adequate organ functions as defined below:
  • Hemoglobin ≥ 8.0 g/dL. White blood cell (WBC) count ≥ 2.5 x 10^9 /L. Neutrophil count ≥ 1.0 × 10^9/L. Platelet count ≥ 50 × 10^9/L. Aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN). Alanine aminotransferase (ALT) ≤ 2.5 × ULN. Serum creatinine ≤ 1.5 × ULN Estimated glomerular filtration rate(eGFR) >=15 mL / min / 1.73m2
  • Female subjects with reproductive potential must have a negative result of serum pregnancy test at the screening visit and urine pregnancy test before the B10 L-BPA administration.
  • Female subject with childbearing potential as well as male subject with reproductive potential must agree to refrain from unprotected sex and use 2 methods of highly effective contraception with their partner (e.g. barrier contraceptives [male condom, female condom, or diaphragm plus spermicide], intrauterine device, hormonal methods [hormone shot or injection, implants, combination oral contraceptives, or patches]) for ≥ 6 months after the BNCT until the end of this study.
  • Physically and mentally capable of participating in the study and willing to adhere to study procedures.
  • Provision of signed informed consent. -

Who cannot join

  • Patients who have an effective standard treatment option available.
  • Lymphoma or other tumor type that is expected to respond to cancer chemotherapy or to a dose of conventional radiation therapy that can be safely given.
  • History of malignancy other than meningioma within 5 years (except carcinoma in situ and non-melanoma skin cancer).
  • A time interval less than 3 months from previous radiation therapy for intracranial region.
  • Patients who had radiation myelitits or radiation necrosis of the brain/brain stem.
  • A time interval less than 3 months from last brain surgery and less than 1 month from previous chemotherapy.
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  • Distant metastasis outside of skull.
  • Imaging studies demonstrating tumor invasion of the carotid artery.
  • Carotid blowout syndrome with active bleeding within 6 months.
  • The investigator will evaluate the subject's condition and determine whether to perform computed tomography angiography (CTA) to assess the health of the subject's vascular system. This evaluation will confirm whether the subject is suitable to participate in the trial.
  • Note: Subjects will be eligible for the study if they have undergone stent implantation and obtained consent from the investigator.
  • Active infections requiring systemic treatment.
  • Patients with severe congestive heart failure or renal failure, as well as myocardial infarction, unstable angina, or poorly controlled arrhythmia within 6 months prior to the scheduled BNCT.
  • Severe comorbidities including but not limited to poorly controlled epilepsy, poorly controlled diabetes mellitus, poorly controlled hypertension, chronic lung diseases, e.g., obstructive pneumonia, interstitial pneumonia, pulmonary fibrosis, and severe emphysema, kidney diseases, e.g., chronic renal failure, acute renal failure, phenylketonuria and nephrotic syndrome, cardiac diseases, e.g., New York Heart Association (NYHA) Functional Classification Class III or IV), phenylketonuria and/or other severe conditions in the opinion of the investigator.
  • Suspected or known hypersensitivity (including allergy) to any of the drug components or contrast media.
  • Subject with hereditary fructose intolerance.
  • With a cardiac pacemaker or an unremovable metal implant in the head and neck region that will interfere with MRI-based dose-planning or tumor response evaluation.
  • Restless subjects who are unable to lie or sit in a cast for 30-60 mins.
  • Any medical or psychiatric conditions that, in the opinion of the investigator, may interfere with optimal participation in the study or place the subject at increased risk of adverse events (AEs).
  • Concurrent systemic cancer treatments, such as chemotherapy, targeted therapy (including cetuximab or EGFR oral tyrosine kinase inhibitors), or immunotherapy.
  • History of substance or alcohol abuse within 6 months prior to the screening visit.
  • Female subject who is planning to be pregnant or lactating during the study period.
  • Subject who is considered unfit to participate in the clinical study as assessed by the investigator -

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Taipei Veterans General Hsopital

    Taipei

Other trials in Taiwan

About this study

Official title: A Phase I/II Study to Evaluate Safety and Efficacy of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA as Boron Carrier in Recurrent Meningioma

This Phase I/II study, titled 'A Study to Evaluate the Safety and Efficacy of Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA as a Boron Carrier in Recurrent Meningioma', aims to assess the efficacy of B10 L-BPA with BNCT in patients with recurrent meningioma. The primary objective is to evaluate the safety and efficacy of BNCT with B10 L-BPA for recurrent meningioma treatment, using the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as the standard for assessment.

Being tested
B10 L-BPA Injection
Medical subject headings
Meningioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • B10 L-BPA InjectionDrug

    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.

Study groups in NCT06668987
Study groupRoleWhat they receive
BNCT, recurrent meningioma.ExperimentalSingle arm treated by BNCT only
Receives: Drug: B10 L-BPA Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and efficacy of BNCT using B10 L-BPA in treating recurrent meningioma

    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.

    Measured: 6 months

Secondary outcomes (3)

  1. Progression-free survival

    PFS is defined as the time from receiving the B10 L-BPA-based BNCT until progressive disease (PD) or death from any cause, whenever comes the first.

    Measured: 6 months

  2. Overall survival

    Overall survival is defined as the time from receiving the B10 L-BPA-based BNCT until death from any cause.

    Measured: 6 months

  3. Quality of life (QoL)

    The EORTC QLQ-C30 questionnaire assesses quality of life through functional, symptom, and global health scales, primarily using a 4-point scale (1='Not at All' to 4='Very Much') and a 7-point scale for two items, where higher scores indicate more symptoms. The QLQ-BN20, specifically designed for brain cancer patients, evaluates symptoms and limitations related to motor and communication issues, with higher scores reflecting greater severity. Together, these tools provide a comprehensive assessment of quality of life for brain cancer patients.

    To determine whether patients' quality of life improves after BNCT with B10 L-BPA, questionnaires will be administered before treatment and at 1, 3, and 6 months post-irradiation. A decrease in QLQ-C30 and QLQ-BN20 scores after irradiation will indicate improved quality of life, and the score of participants showing this improvement will be used to evaluate the benefits of BNCT with B10 L-BPA.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2024
  2. Study start14 Oct 2024
  3. Primary completion7 Aug 2025
  4. Study completion23 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06668987
Sponsor's protocol ID
2024-08-015B
Status last verified
May 2026
First submitted
27 Oct 2024
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing B10 L-BPA Injection in people with Meningioma and Boron Neutron Capture Therapy, run by Heron Neutron Medical Corp. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and efficacy of BNCT using B10 L-BPA in treating recurrent meningioma (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06668987.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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