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

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ClinicalTrials.gov Identifier: NCT04906070
Recruitment Status : Recruiting
First Posted : May 28, 2021
Last Update Posted : May 28, 2021
Sponsor:
Information provided by (Responsible Party):
Hekabio

Tracking Information
First Submitted Date  ICMJE May 25, 2021
First Posted Date  ICMJE May 28, 2021
Last Update Posted Date May 28, 2021
Actual Study Start Date  ICMJE May 25, 2019
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2021)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2021)
Adverse Events [ Time Frame: 12 weeks after HB-001 insertion ]
The incidence, frequency, severity and causality of adverse events related to the HB-001
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy (HB-001) by Alpha-particle Sources for Recurrent Malignant Solid Tumors in Japan
Official Title  ICMJE Study of the Safety and Efficacy of Radiation Therapy (HB-001) by Alpha-particle Sources for Recurrent Malignant Solid Tumors in Japan
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Head and Neck Cancer
Intervention  ICMJE 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 Name: DaRT(Diffusing Alpha Radiation Emitters Therapy)
Study Arms  ICMJE Experimental: HB-001 DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Intervention: Device: HB-001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 25, 2021)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Toshiro Mabuchi +81-3-6205-7585 toshiro.mabuchi@hekabio.com
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04906070
Other Study ID Numbers  ICMJE HB-AT-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hekabio
Study Sponsor  ICMJE Hekabio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Toshiro Mabuchi Hekabio
PRS Account Hekabio
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP