Breast CancerNCT04906070
Radiation Therapy (HB-001) by Alpha-particle Sources for Recurrent Malignant Solid Tumors in Japan
A study testing HB-001 in people with Breast Cancer and Head and Neck Cancer, run by Hekabio at 4 sites in Japan.
Trial summary
An intratumoral alpha particle based approach for cancer treatment using diffusion alpha-emitting radiation therapy (DaRT) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Head and Neck Cancer
- What is being tested?
- HB-001
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 4 sitesJapan
- Study dates
- 25 May 2019to 27 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Head and neck cancer or breast cancer patients with histopathological proven malignancies who have a history of radiation therapy and who have been diagnosed with refractory malignancies with or without medical treatment.
- Tumor size is 5 cm or less in the longest diameter
- Age 18 years or older
- Eastern Cooperative Oncology Group performance status is 2 or less
- Life expectancy: 6 months or longer
- Vital signs (systolic and diastolic blood pressure, pulse rate, body temperature, and respiratory rate) are stable
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- Platelet count >= 100,000/mm3 and prothrombin time Prothrombin Time-International Normalized Ratio <= 1.8
- Women of childbearing potential have to be confirmed not pregnant by a pregnancy test and have to agree to prevent conception throughout the study.
- Having received explanation about the study, consented to participate in the study and signed the informed consent form.
- Measurable disease according to RECIST v1.1
Who cannot join
- The size of the tumor more than 5 cm in the maximum diameter.
- ECOG performance status is 3 or higher
- Continuously receiving medication that may have a significant impact on the evaluation of safety or efficacy, such as immunosuppressants and/or corticosteroids.
- History of serious allergy to the medicine for the treatments like anesthesia.
- There are tumors to be preferentially treated such as metastatic lesion other than the target tumor
- Having received chemotherapeutic drugs (except hormonal agents), immunotherapeutic agents, and molecular targeting agents in the past 30 days, which may affect the assessment of the safety or efficacy of the HB-001 brachytherapy.
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- Having received immune checkpoint inhibitor in the past 2 months, which may affect the assessment of the safety or efficacy of the HB-001 brachytherapy.
- Having participated in different clinical studies in the past 30 days, which may affect the assessment of the safety or efficacy of HB-001 brachytherapy
- Pregnant women or breast-feeding mothers
- Those who do not wish to sign the informed consent form
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Tohoku University Hospital
Miyagi, 980-8574
Kansai Medical University Hospital
Osaka, 573-1191
National Cancer Center Hospital
Tokyo, 104-0045
Tokyo Medical And Dental University Medical Hospital
Tokyo, 113-8519
About this study
Official title: Study of the Safety and Efficacy of Radiation Therapy (HB-001) by Alpha-particle Sources for Recurrent Malignant Solid Tumors in Japan
An intratumoral alpha particle based approach for cancer treatment using diffusion alpha-emitting radiation therapy (DaRT)
Read the detailed description
This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor. This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients. Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds. Reduction in tumor size 70 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).
- Conditions
- Breast Cancer, Head and Neck Cancer
- Being tested
- HB-001
- Medical subject headings
- Breast Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB-001Device
Also called DaRT(Diffusing Alpha Radiation Emitters Therapy)
An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
| Study group | Role | What they receive |
|---|---|---|
| HB-001 DaRT Seeds | Experimental | Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds Receives: Device: HB-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response to HB-001
Assessment of tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Measured: 9 - 11 weeks after HB-001 seed insertion
Secondary outcomes (1)
Adverse Events
The incidence, frequency, severity and causality of adverse events related to the HB-001
Measured: 12 weeks after HB-001 insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start25 May 2019
- Primary completion31 Mar 2022
- Study completion27 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hekabio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshiro Mabuchi, Study director, Hekabio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906070
- Sponsor's protocol ID
- HB-AT-001
- Status last verified
- Jun 2022
- First submitted
- 25 May 2021
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety and Efficacy of Radiation Therapy (HB-001) by Alpha-particle Sources for Recurrent Malignant Solid Tumors in Japan
- ClinicalTrials.gov ID
- NCT04906070
- Acronym / sponsor ID
- HB-AT-001
- Conditions
- Breast Cancer, Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- HekabioIndustry (pharma, biotech, devices)
- Study start
- 25 May 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An intratumoral alpha particle based approach for cancer treatment using diffusion alpha-emitting radiation therapy (DaRT)
Detailed description
This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor. This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients. Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds. Reduction in tumor size 70 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HB-001 DaRT Seeds | Experimental | Device: HB-001Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Head and neck cancer or breast cancer patients with histopathological proven malignancies who have a history of radiation therapy and who have been diagnosed with refractory malignancies with or without medical treatment.
- Tumor size is 5 cm or less in the longest diameter
- Age 18 years or older
- Eastern Cooperative Oncology Group performance status is 2 or less
- Life expectancy: 6 months or longer
Key exclusion criteria (10 listed)
- The size of the tumor more than 5 cm in the maximum diameter.
- ECOG performance status is 3 or higher
- Continuously receiving medication that may have a significant impact on the evaluation of safety or efficacy, such as immunosuppressants and/or corticosteroids.
- History of serious allergy to the medicine for the treatments like anesthesia.
- There are tumors to be preferentially treated such as metastatic lesion other than the target tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB-001Also: DaRT(Diffusing Alpha Radiation Emitters Therapy)An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms. | Device | HB-001 DaRT Seeds |
Primary outcome
Tumor response to HB-001
Time frame: 9 - 11 weeks after HB-001 seed insertion
Assessment of tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
1 secondary outcome
Adverse Events
Time frame: 12 weeks after HB-001 insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toshiro Mabuchi study director
Hekabio
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HB-001 in people with Breast Cancer and Head and Neck Cancer, run by Hekabio at 4 sites in Japan.
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 10 inclusion and 10 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: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response to HB-001 (time frame: 9 - 11 weeks after HB-001 seed insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2022.