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

NCT06952868 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-06-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Heron Neutron Medical Corp.

    collaborator INDUSTRY

  • China Medical University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-23
Primary Completion
2026-08-31
Completion
2027-02-28

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06952868 on ClinicalTrials.gov