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

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)

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Head and Neck Cancer
• Intervention / Treatment: Device: HB-001

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Miyagi, Japan, 980-8574
    • Tohoku University Hospital
  • Osaka, Japan, 573-1191
    • Kansai Medical University Hospital
  • Tokyo, Japan, 104-0045
    • National Cancer Center Hospital
  • Tokyo, Japan, 113-8519
    • Tokyo Medical and Dental University Medical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. Tumor size is 5 cm or less in the longest diameter
3. Age 18 years or older
4. Eastern Cooperative Oncology Group performance status is 2 or less
5. Life expectancy: 6 months or longer
6. Vital signs (systolic and diastolic blood pressure, pulse rate, body temperature, and respiratory rate) are stable
7. Platelet count >= 100,000/mm3 and prothrombin time Prothrombin Time-International Normalized Ratio <= 1.8
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.
9. Having received explanation about the study, consented to participate in the study and signed the informed consent form.
10. Measurable disease according to RECIST v1.1

Exclusion Criteria:

1. The size of the tumor more than 5 cm in the maximum diameter.
2. ECOG performance status is 3 or higher
3. Continuously receiving medication that may have a significant impact on the evaluation of safety or efficacy, such as immunosuppressants and/or corticosteroids.
4. History of serious allergy to the medicine for the treatments like anesthesia.
5. There are tumors to be preferentially treated such as metastatic lesion other than the target tumor
6. 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.
7. 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.
8. 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
9. Pregnant women or breast-feeding mothers
10. Those who do not wish to sign the informed consent form

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HB-001 DaRT Seeds; Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds	Device: HB-001; 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.; Other Names: DaRT(Diffusing Alpha Radiation Emitters Therapy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor response to HB-001	Assessment of tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)	9 - 11 weeks after HB-001 seed insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	The incidence, frequency, severity and causality of adverse events related to the HB-001	12 weeks after HB-001 insertion

Collaborators and Investigators

• Sponsor: Hekabio
• Investigators: Study Director: Toshiro Mabuchi, Hekabio

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2019
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): May 27, 2022

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: HB-AT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No