NCT06952868

Boron Neutron Capture Therapy With B10 L-BPA for Unresectable Recurrent Head and Neck Cancers

A Phase II Study to Evaluate the Efficacy and Safety of the Boron Neutron Capture Therapy (BNCT) Using the B10 L-BPA as Boron Carrier in Patients With Unresectable Recurrent Head and Neck Cancers

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This Phase II study, titled "A Phase II Study to Evaluate the Efficacy and Safety of Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Patients with Unresectable Recurrent Head and Neck Cancers," aims to assess the efficacy and safety of B10 L-BPA-based BNCT in this patient population. The primary objective is to evaluate its efficacy, while secondary objectives include assessing safety, survival outcomes, tumor response, and the pharmacokinetics (PK) profile of B10 L-BPA and boron.

Conditions

• Head and Neck Cancer
• Boron Neutron Capture Therapy

Interventions

Type	Name	Description
DRUG	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. This single arm of the study is designed to evaluate the therapeutic efficacy of BNCT, wherein patients receive B10 L-BPA administration followed by neutron irradiation.

Timeline

• Start date: 2025-05-23
• Primary completion: 2026-08-31
• Completion: 2027-02-28
• First posted: 2025-05-01
• Last updated: 2025-06-12

Locations

2 sites across 1 country: Taiwan