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

NCT07003139 | Recruiting Phase 1

• 1 other identifier: CMUH114-REC1-016
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Malignant Brain Tumors

Keywords

L-4-(10B)Boronophenylalanine; (10B)-4-Borono-L-phenylalanine; BNCT; Malignant Brain Tumors; Boron Neutron Capture Therapy; Borofalan (10B)

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months

• 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.

  6 months

Secondary Outcomes (3)

• Progression-free survival

  6 months

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

  6 months

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

  6 months

Other Outcomes (1)

• The population of circulating immune cells

  6 months

Study Arms (1)

Boron Neutron Capture Therapy

EXPERIMENTAL

Single arm treated by BNCT only

Drug: B10 L-BPA Injection

Interventions

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.

Boron Neutron Capture Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead
• Heron Neutron Medical Corp.: collaborator

Study Sites (2)

China Medical University Hsinchu Hospital

Hsinchu, 302, Taiwan

NOT YET RECRUITING

China Medical University Hospital

Taichung, 40447, Taiwan

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: June 4, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

TW (2)