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Malignant Brain TumorsPhase 1/2NCT07003139

A Study of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Malignant Brain Tumors

A Phase 1/2 study testing B10 L-BPA Injection in people with Malignant Brain Tumors, run by China Medical University Hospital at 2 sites in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This Phase I/II study, titled '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 Malignant Brain Tumors.', aims to assess the efficacy of B10 L-BPA with BNCT in patients with malignant brain tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Brain Tumors
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
2 sitesTaiwan
Study dates
30 Jun 2025to Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Age of 18 years and older.
  • Patients with malignant brain tumors confirmed by histological and/or medical imaging, classified as WHO Grade 3 or 4 according to the World Health Organization of tumors of the central nervous system (CNS) classification, excluding those with histologically confirmed Grade 3 intracranial ependymoma, medulloblastoma, and primary CNS lymphoma.
  • 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.
  • Within 4 weeks prior to the screening visit, measurable disease by magnetic resonance imaging (MRI) and/or computed tomography (CT) scan showing a volume ≦ 250 cm^3, longest dimension < 7 cm.
  • At least one measurable lesion that can be assessed by RECIST v1.1.
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  • 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 10^3/μL.
  • Neutrophil count ≥ 1.5 × 10^3/μL.
  • Platelet count ≥ 80 × 10^3/μL.
  • 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 / 1.73m^2
  • 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. However, if the subject has been menopausal for at least 2 years (more than 24 months since the last menstrual period) or uses surgical birth control, testing is not required.
  • 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 with malignant brain tumors complicated by any of the following conditions:
  • Extracranial metastases.
  • Multiple intracranial lesions on both sides.
  • The investigator assesses that the subject has concurrent infections or other malignant tumors and is not suitable to participate in the trial.
  • Patients with malignant brain tumors are considered eligible for standard surgical treatment that is effective against the tumor.
  • A time interval less than 3 months from previous radiation therapy for intracranial region.
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  • A time interval less than 3 months from last brain surgery (excluding drainage procedures and biopsy) and less than 1 month from previous chemotherapy.
  • The adverse event of previous anti-tumor therapy were NCI-CTCAE V5.0 grade evaluation ≧ Class 3 (excluding alopecia and peripheral neuropathy).
  • Received or expect to receive any investigational drug, biologic or device within 1 month prior to the scheduled BNCT.
  • Patients receiving or expected to receive vascular endothelial growth factor inhibitors (except bevacizumab) or live attenuated vaccines within 1 month prior to the scheduled BNCT.
  • Patients received major surgery within 1 month prior to the scheduled BNCT or are still recovering from a previous surgery. The investigator will evaluate the subject's condition when the subject receives major surgery. Major surgery is defined as procedure that requires general anaesthesia and/or anticipated hospitalization longer than 24 hours, with significant risk of blood loss or complications. Examples include heart surgery, organ transplants, and prolonged operations such as certain back surgeries. Procedures such as stent implantation, biopsy, endoscopy, and day surgery are excluded.
  • Patients who had radiation myelitits or radiation necrosis of the brain/brain stem.
  • Patient who is prone to vascular rupture during the trial as assessed by the investigator. The Patient will be eligible for the study if they have undergone stent implantation and obtained consent from the investigator.
  • 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 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 boron or any component of the study drug or contrast media.
  • Subject with hereditary fructose intolerance.
  • With a cardiac pacemaker or will interfere with MRI-based or CT-based dose-planning or tumor response evaluation.
  • Restless subjects who are unable to lie or sit in a cast for more than 30 minutes.
  • 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).
  • 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.
  • Subject who has received prior BNCT.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan2 sites, 2 recruiting

  • China Medical University Hsinchu Hospital

    Hsinchu, 302

    Yu-Cheng Kuo, +886-3-5580558 ext. 1479, shapico22@gmail.com

    Dr. Kuo

    Recruiting

  • China Medical University Hospital

    Taichung, 40447

    Kun-San Chao, +886-4-22052121 ext. 12976, biotechgateway@gmail.com

    Dr. Chao

    Recruiting

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 Malignant Brain Tumors.

This Phase I/II study, titled '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 Malignant Brain Tumors.', aims to assess the efficacy of B10 L-BPA with BNCT in patients with malignant brain tumors. The primary objective is to evaluate the safety and efficacy of BNCT with B10 L-BPA for malignant brain tumors treatment, using the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as the standard for assessment.

Read the detailed description

Not provided

Being tested
B10 L-BPA Injection
Keywords
L-4-(10B)Boronophenylalanine, (10B)-4-Borono-L-phenylalanine, BNCT, Malignant Brain Tumors, Boron Neutron Capture Therapy, Borofalan (10B)

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 NCT07003139
Study groupRoleWhat they receive
Boron Neutron Capture TherapyExperimentalSingle 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 of BNCT using B10 L-BPA in treating malignant brain tumors

    Safety will be assessed by monitoring the occurrence, severity, and relationship of treatment-emergent adverse events (TEAEs), including serious adverse events and events leading to permanent discontinuation of therapy, according to protocol definitions and CTCAE v5.0.

    Measured: 6 months

  2. Efficacy of BNCT using B10 L-BPA in treating malignant brain tumors

    Efficacy of BNCT with B10 L-BPA for treating malignant brain tumors will be assessed by the percentage of subjects achieving complete response (CR) and partial response (PR). Tumor response will be evaluated using RECIST v1.1 criteria via high-resolution CT or MRI.

    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. PFS is evaluated by imaging according to the RECIST v1.1 criteria.

    Measured: 6 months

  2. Change in Quality of Life as Measured by the EORTC QLQ-C30 Questionnaire

    The EORTC QLQ-C30 is a validated questionnaire that evaluates cancer patients' quality of life through functional, symptom, and global health scales. It 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.

    Measured: 6 months

  3. Change in Quality of Life as Measured by the EORTC QLQ-BN20 Questionnaire

    The EORTC QLQ-BN20 is a validated module for brain tumor patients that assesses disease- and treatment-specific symptoms such as motor dysfunction, communication issues, and visual or cognitive changes. It uses a 4-point scale (1 = "Not at All" to 4 = "Very Much"), where higher scores indicate more severe symptoms.

    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 posted4 Jun 2025
  2. Study start30 Jun 2025
  3. Primary completionJun 2026 (estimated)
  4. Study completionDec 2026 (estimated)

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 (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07003139
Sponsor's protocol ID
CMUH114-REC1-016
Status last verified
May 2026
First submitted
5 May 2025
Last updated
13 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 Malignant Brain Tumors, run by China Medical University Hospital at 2 sites 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 21 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: looking for participants now, as of the sponsor's last update on 13 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 2 sites 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?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of BNCT using B10 L-BPA in treating malignant brain tumors (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT07003139.

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 13 May 2026.

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