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RECRUITING
NCT07003139
PHASE1/PHASE2

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

Sponsor: China Medical University Hospital

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-06-30

Completion Date

2026-12

Last Updated

2025-11-18

Healthy Volunteers

No

Interventions

DRUG

B10 L-BPA Injection

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.

Locations (2)

China Medical University Hsinchu Hospital

Hsinchu, Taiwan

China Medical University Hospital

Taichung, Taiwan