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Head and Neck CancerPhase 2NCT07795034

To Evaluate the Efficacy and Safety of Accelerator-Based Boron Neutron Capture Therapy (AB-BNCT) Combined With NBB-001 and NBB-002 for Patients With Recurrent Head and Neck Malignancies

A Phase 2 study testing Boron Neutron Capture Therapy in people with Head and Neck Cancer, run by Neuboron Bio-SciTech Co., Ltd. at 1 site in China.

Recruiting

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

Sites and contacts
Official record
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Trial summary

This Phase II study, titled 'A Single-Arm, Open-Label Phase II Clinical Trial to Evaluate the Efficacy and Safety of Accelerator-Based Boron Neutron Capture Therapy (AB-BNCT) Combined with NBB-001 and NBB-002 for Patients with Recurrent Head and Neck Malignancies.', aims to assess the efficacy and safety of BNCT in… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Head and Neck Cancer
What is being tested?
Boron Neutron Capture Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
31 Aug 2026to Dec 2028
Phase
Phase 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form;
  • Age>=18 years old and <=75 years old, gender is not limited;
  • Histologically or cytologically confirmed head and neck malignancies.
  • Patients have head and neck malignancies with local recurrence or regional lymph node recurrence, with prior failure of or intolerance to local therapy plus at least one line of systemic therapy, or no available standard treatment options.
  • Multiple target lesions need to be covered in a single treatmentMultiple target lesions need to be covered in a single treatment
  • At least 1 measurable tumor lesion according to RECIST v1.1 criteria; 7.18F-BPA PET/CT scan demonstrated that the boron concentration ratio (TNR) of tumor and normal tissue should be ≥2.5
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  • 8.Adequate hematologic function, liver function and renal function: 9.Expected survival >=3 months; 10.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2; 11.For patients with prior radiotherapy, the total cumulative dose to target lesions can not exceed 75 Gy.
  • 12.The adverse reactions of previous anti-tumor therapy must resolve to Grade ≤1 according to NCI CTCAE Version 6.0.
  • 13.Female and male patients of reproductive potential must agree to utilize medically accepted effective contraception from initiation of informed consent until 6 months following BNCT treatment.

Who cannot join

  • Subjects with known hypersensitivity to any active ingredient or excipient of the investigational product, severe fructose intolerance, or a history of other severe allergic reactions who are judged by the investigator to be unsuitable for participation in this trial.
  • Subjects with active multiple primary malignancies.
  • Subjects with multiple distant metastases.
  • There is a risk of arterial hemorrhage associated with tumor involvement, and there is no effective preventive measure
  • Subjects who received radiotherapy to target lesions within 3 months prior to administration of NBB-001.
  • Subjects who have received prior particle implantation therapy.
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  • Subjects receiving any systemic anti-tumor therapy (including systemic chemotherapy, immunotherapy, targeted therapy, etc.) within 4 weeks or 5 half-lives prior to NBB-001 administration; or subjects receiving anti-tumor Chinese herbal medicines or proprietary Chinese medicines within 2 weeks before BNCT treatment.
  • Subjects who have received major surgery involving vital organs (excluding needle biopsy) or experienced significant trauma within 4 weeks prior to NBB-001 administration.
  • Subjects receiving any investigational medicinal product or investigational devices within 4 weeks prior to NBB-002 administration
  • Subjects who have experienced a serious arterial/venous thromboembolic event within 6 months prior to administration of NBB-002 or have a prior history of stroke; subjects with decompensated congestive heart failure (New York Heart Association [NYHA] Class III or IV), or severe cardiovascular disease confirmed by echocardiography and 12-lead electrocardiogram, who are judged by the investigator to be ineligible for participation in this trial.
  • Subjects with clinically significant active COPD or other severe chronic respiratory diseases, or active infection with clinical manifestations or organ dysfunction, who are deemed ineligible for this trial by the investigator
  • Subjects with evidence of other serious or uncontrolled systemic diseases deemed by the investigator.
  • Subjects diagnosed with phenylketonuria (PKU).
  • Subjects with any of the following: a) A cardiac pacemaker; b) Non-removable metallic implants within the single treatment area assessed by the investigator to preclude treatment; or non-removable metallic implants outside the single treatment area that cannot be effectively shielded and are assessed by the investigator to preclude treatment.
  • Known history of drug or alcohol dependence.
  • Subjects with a history of immunodeficiency, including positive HIV antibody testing.
  • Subjects with other conditions deemed by the investigator to potentially affect compliance or render them unsuitable for participation in this trial, such as diseases that may impair the ability to adhere to trial requirements or compromise capacity to provide informed consent.

Trial locations and contacts

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

Jianji Pan contact

+86 13600889160

panjianji@126.com

China1 site, 1 recruiting

  • Xiamen Humanity Hospital

    Xiamen, Fujian, 361006

    Jianji Pan, +86 13600889160, panjianji@126.com

    Recruiting

Other trials in China

About this study

Official title: A Single-Arm, Open-Label Phase II Clinical Trial to Evaluate the Efficacy and Safety of Accelerator-Based Boron Neutron Capture Therapy (AB-BNCT) Combined With NBB-001 and NBB-002 for Patients With Recurrent Head and Neck Malignancies

This Phase II study, titled 'A Single-Arm, Open-Label Phase II Clinical Trial to Evaluate the Efficacy and Safety of Accelerator-Based Boron Neutron Capture Therapy (AB-BNCT) Combined with NBB-001 and NBB-002 for Patients with Recurrent Head and Neck Malignancies.', aims to assess the efficacy and safety of BNCT in patients with Recurrent Head and Neck Malignancies.

Primary Objective: To evaluate the efficacy of Boron Neutron Capture Therapy (BNCT) in patients with recurrent head and neck malignancies.Secondary Objectives:To evaluate the efficacy of BNCT in patients with recurrent head and neck malignancies based on secondary efficacy endpoints;To characterize the pharmacokinetic (PK) profiles and radiation dosimetric characteristics of NBB-002 in patients with recurrent head and neck malignancies;To evaluate the safety of BNCT in patients with recurrent head and neck malignancies;To evaluate the equipment performance and equipment deficiencies of the boron neutron capture therapy system.

Being tested
Boron Neutron Capture Therapy
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Boron Neutron Capture TherapyRadiation

    Accelerator-Based Boron Neutron Capture Therapy (AB-BNCT) Combined with NBB-001（BPA） and NBB-002(18F-BPA) for Patients with Recurrent Head and Neck Malignancies

Study groups in NCT07795034
Study groupRoleWhat they receive
Boron Neutron Capture TherapyExperimentalSingle arm treated by BNCT only
Receives: Radiation: Boron Neutron Capture Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Measured: 90 days post-treatment

Secondary outcomes (6)

  1. Local Control Rate (LCR)

    Measured: 2 years

  2. Treatment toxicities

    CTCAE V6.0

    Measured: 2 years

  3. Disease Control Rate (DCR)

    Measured: 2 years

  4. Duration of Overall Response (DOR)

    Measured: 2 years

  5. Progression-Free Survival (PFS)

    Measured: 2 years

  6. Overall survival (OS)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2026
  2. Study start31 Aug 2026 (estimated)
  3. Primary completionAug 2027 (estimated)
  4. Study completionDec 2028 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07795034
Sponsor's protocol ID
BNCT-II-201
Status last verified
Sep 2026
First submitted
18 Aug 2026
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Boron Neutron Capture Therapy in people with Head and Neck Cancer, run by Neuboron Bio-SciTech Co., Ltd. at 1 site in China.

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 9 inclusion and 17 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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 phase mean?

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?

Contact Jianji Pan (+86 13600889160, panjianji@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: 90 days post-treatment). 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 NCT07795034.

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 8 Sep 2026.

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