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Radiation Therapy (HB-001) by Alpha-particle Sources for Recurrent Malignant Solid Tumors in Japan

Primary Purpose

Breast Cancer, Head and Neck Cancer

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

HB-001

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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.
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

Sites / Locations

Tohoku University Hospital
Kansai Medical University Hospital
National Cancer Center Hospital
Tokyo Medical And Dental University Medical Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HB-001 DaRT Seeds

Arm Description

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Outcomes

Primary Outcome Measures

Tumor response to HB-001

Assessment of tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)

Secondary Outcome Measures

Adverse Events

The incidence, frequency, severity and causality of adverse events related to the HB-001

Full Information

NCT ID

NCT04906070

First Posted

May 25, 2021

Last Updated

June 2, 2022

Sponsor

Hekabio

1. Study Identification

Unique Protocol Identification Number

NCT04906070

Brief Title

Radiation Therapy (HB-001) by Alpha-particle Sources for Recurrent Malignant Solid Tumors in Japan

Official Title

Study of the Safety and Efficacy of Radiation Therapy (HB-001) by Alpha-particle Sources for Recurrent Malignant Solid Tumors in Japan

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

May 25, 2019 (Actual)

Primary Completion Date

March 31, 2022 (Actual)

Study Completion Date

May 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hekabio

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Head and Neck Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HB-001 DaRT Seeds

Arm Type

Experimental

Arm Description

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Intervention Type

Device

Intervention Name(s)

HB-001

Other Intervention Name(s)

DaRT(Diffusing Alpha Radiation Emitters Therapy)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Tumor response to HB-001

Description

Assessment of tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)

Time Frame

9 - 11 weeks after HB-001 seed insertion

Secondary Outcome Measure Information:

Title

Adverse Events

Description

The incidence, frequency, severity and causality of adverse events related to the HB-001

Time Frame

12 weeks after HB-001 insertion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Toshiro Mabuchi

Organizational Affiliation

Hekabio

Official's Role

Study Director

Facility Information:

Facility Name

Tohoku University Hospital

City

Miyagi

ZIP/Postal Code

980-8574

Country

Japan

Facility Name

Kansai Medical University Hospital

City

Osaka

ZIP/Postal Code

573-1191

Country

Japan

Facility Name

National Cancer Center Hospital

City

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

Tokyo Medical And Dental University Medical Hospital

City

Tokyo

ZIP/Postal Code

113-8519

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Radiation Therapy (HB-001) by Alpha-particle Sources for Recurrent Malignant Solid Tumors in Japan

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