ZETAMET™ BONE GRAFT IN THE REPAIR OF BONE DEFECTS FROM METASTATIC BREAST CANCER IN VERTEBRAL BONES (ZGMBC)

January 14, 2026 updated by: Zetagen Therapeutics, Inc

FEASIBILITY STUDY OF ZETAMET™ BONE GRAFT IN THE REPAIR OF BONE DEFECTS FROM METASTATIC BREAST CANCER IN THE SPINAL VERTEBRAL BODY: A PHASE 2A, MULTICENTER, OPEN-LABELED, SINGLE-ARM STUDY

ZetaMet™ is indicated for patients with destructive, lytic lesions due to metastatic breast cancer to bone, with or without involvement of other sites, with at least one metastatic lesion located in a vertebral body of the spine, and a Spinal Instability Neoplastic Score (SINS) ≥3 and ≤9. ZetaMet™ is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. ZetaMet™ is only for implantation into the vertebral body.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label single-arm study. Subjects (N=10) will be recruited from up to 4 Investigational Sites in Canada. Key inclusion criteria are metastatic breast cancer to bone with at least one lytic metastatic lesion located in a vertebral body of the spine and a SINS ≥3 and ≤9. ZetaMet™ will be percutaneously implanted into the vertebral body defect(s) created by the lytic metastatic tumor. Post-operative care will be per standard of care (SOC) at the Investigational Site. Subjects will be followed for 180 days post-treatment. If post-surgical radiation treatment is planned, it should not occur for at least 84 days post-surgery to allow for bone formation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver Coastal Health Research Institute
    • Quebec
      • Montreal, Quebec, Canada, H3G1A4
        • McGill University Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 22 (inclusive) and 75 years (inclusive) at the time of enrollment.
  • Life expectancy of 12 months or more.
  • Female patient with histologically confirmed diagnosis of primary breast cancer.
  • Metastatic breast cancer to bone, with or without involvement of other sites (patients with single metastasis qualify)
  • At least one lytic metastatic lesion located in the vertebral body of the spine.
  • Normal spinal alignment.
  • SINS ≥3 and ≤9.
  • Signed and dated Informed Consent Form (ICF).
  • Patient is willing and able to participate in required follow-up visits at the Investigational Site and to complete study procedures and questionnaires.

Exclusion Criteria:

  • Vertebral body collapse.
  • Spinal cord compression.
  • Known allergy to Investigational Device materials.
  • Using medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., chronic systemic steroids).
  • Current tobacco smoker or stopped smoking in past 6 months.
  • Uncontrolled diabetes mellitus, HbAIC cutoff.
  • An active systemic infection (e.g., hepatitis, acquired immunodeficiency syndrome (AIDS), AIDS-related complex (ARC).
  • Currently participating in any investigational trial not related to this trial.
  • Any other severe acute or chronic medical condition that may interfere with the interpretation of the trial results, in the judgment of the PI, which would make the patient inappropriate for entry into this trial.
  • Pregnant or planning to become pregnant during the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Investigational Device ZetaMet™
ZetaMet™ is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. ZetaMet™ is only for implantation into the vertebral body.
Combination product: ZetaMet™ (ZetaFuse™ Bone Graft)
ZetaMet™ (ZetaFuse™ Bone Graft) will be percutaneously implanted into the vertebral body defect(s) created by the lytic metastatic tumor.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Skeletal Related Events (SREs)
Time Frame: Day 0 up to Day 180
SREs include pathologic fracture, spinal cord compression, radiation therapy to bone, or surgical intervention.
Day 0 up to Day 180
Number of subjects with at least one adverse event (AE)
Time Frame: Day 0 up to Day 180
An AE is any unfavorable sign, symptom, or disease temporally associated with study participation, including the use of the Investigational Device and all study procedures. An AE may or may not be related to the use of the Investigational Device or a study procedure. AEs may include abnormal laboratory findings, radiologic events, medical complications, and changes from baseline in the subject's condition.
Day 0 up to Day 180
Number of subjects with at least one procedure-related AE
Time Frame: Day 0 up to Day 180
A procedure-related AE is any unfavorable sign, symptom, or disease temporally associated with any study procedure. These AEs may include abnormal laboratory findings, radiologic events, medical complications, and changes from baseline in the subject's condition, related to any study procedure.
Day 0 up to Day 180
Number of subjects with at least one device-related AE
Time Frame: Day 0 up to Day 180
A device-related AE is any unfavorable sign, symptom, or disease temporally associated with the Investigational Device. These AEs may include abnormal laboratory findings, radiologic events, medical complications, and changes from baseline in the subject's condition, related to the Investigational Device.
Day 0 up to Day 180
Change in SINS assessment at 21 days compared to baseline
Time Frame: Day 0 to Day 21 postoperatively
The SINS is a scoring system based on six parameters; one for pain and five radiographic parameters (location, bone lesion quality, spinal alignment, vertebral body collapse and involvement of posterolateral elements). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability.
Day 0 to Day 21 postoperatively
Change in SINS assessment at 42 days compared to baseline
Time Frame: Day 0 to Day 42 postoperatively
The SINS is a scoring system based on six parameters; one for pain and five radiographic parameters (location, bone lesion quality, spinal alignment, vertebral body collapse and involvement of posterolateral elements). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability.
Day 0 to Day 42 postoperatively
Change in SINS assessment at 84 days compared to baseline
Time Frame: Day 0 to Day 84 postoperatively
The SINS is a scoring system based on six parameters; one for pain and five radiographic parameters (location, bone lesion quality, spinal alignment, vertebral body collapse and involvement of posterolateral elements). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability.
Day 0 to Day 84 postoperatively
Change in SINS assessment at 180 days compared to baseline
Time Frame: Day 0 to Day 180 postoperatively
The SINS is a scoring system based on six parameters; one for pain and five radiographic parameters (location, bone lesion quality, spinal alignment, vertebral body collapse and involvement of posterolateral elements). The SINS ranges 0-18. Score in range 0-6 denote stability; 7-12 intermediate instability and 13-18 instability.
Day 0 to Day 180 postoperatively
Change in Short Form 12v2 (SF-12v2) score compared to baseline
Time Frame: Day 0 to Day 180 postoperatively
The 12-Item Short Form Survey version 2 (SF-12v2) is a shortened version of the SF-36v2 designed to reduce respondent burden while achieving minimum standards of precision for purposes of group comparisons involving multiple health dimensions. The SF-12v2 is given at baseline and at 180 days postoperatively.
Day 0 to Day 180 postoperatively
Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 21 days compared to baseline
Time Frame: Day 0 to Day 21 postoperatively
The Numeric Rating Scale (NRS) is a psychometric response scale which is commonly used in questionnaires and studies to measure the intensity of pain. In this study we will use a 11-point (0-10) scale where "0" denotes no pain and "10" is the worst imaginable pain.
Day 0 to Day 21 postoperatively
Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 42 days compared to baseline
Time Frame: Day 0 to Day 42 postoperatively
The Numeric Rating Scale (NRS) is a psychometric response scale which is commonly used in questionnaires and studies to measure the intensity of pain. In this study we will use a 11-point (0-10) scale where "0" denotes no pain and "10" is the worst imaginable pain.
Day 0 to Day 42 postoperatively
Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 84 days compared to baseline
Time Frame: Day 0 to Day 84 postoperatively
The Numeric Rating Scale (NRS) is a psychometric response scale which is commonly used in questionnaires and studies to measure the intensity of pain. In this study we will use a 11-point (0-10) scale where "0" denotes no pain and "10" is the worst imaginable pain.
Day 0 to Day 84 postoperatively
Change in Back-specific Numeric Rating Scale for Pain (Back NRS) at 180 days compared to baseline
Time Frame: Day 0 to Day 180 postoperatively
The Numeric Rating Scale (NRS) is a psychometric response scale which is commonly used in questionnaires and studies to measure the intensity of pain. In this study we will use a 11-point (0-10) scale where "0" denotes no pain and "10" is the worst imaginable pain.
Day 0 to Day 180 postoperatively
Change in vertebral body defect size measured by CT at 42 days compared to baseline
Time Frame: Day 0 to Day 42 postoperatively
Vertebral body defect size measured by CT
Day 0 to Day 42 postoperatively
Change in vertebral body defect size measured by planar radiographs at 42 days compared to baseline
Time Frame: Day 0 to Day 42 postoperatively
Vertebral body defect size and planar radiographs
Day 0 to Day 42 postoperatively
Change in vertebral body defect size measured by CT at 180 days compared to baseline
Time Frame: Day 0 to Day 180 postoperatively
Vertebral body defect size measured by CT
Day 0 to Day 180 postoperatively
Change in vertebral body defect size measured by planar radiographs at 180 days compared to baseline
Time Frame: Day 0 to Day 180 postoperatively
Vertebral body defect size measured by planar radiographs
Day 0 to Day 180 postoperatively
Duration of use of postoperative prescription opioid
Time Frame: Day 180 postoperatively
The average per group duration of intake of opioids in the post-operative setting.
Day 180 postoperatively
Daily dose of postoperative prescription opioid use
Time Frame: Day 180 postoperatively
The average per group dosage of opioids in the post-operative setting.
Day 180 postoperatively
Naloxone concentrations in blood collected from patients at 30 minutes following the vertebroplasty procedure
Time Frame: 30 minutes following the placement of the surgical bandage
Two blood samples (5 mL each) of whole blood are collected at 30 minutes following the placement of the surgical bandage (n=2 blood collections of a total of 10 mL per patient). When naloxone blood concentrations remain below 1.016-ng/mL, there is not a reduction in opioid analgesia
30 minutes following the placement of the surgical bandage
Naloxone concentrations in blood collected from patients at 60 minutes after the vertebroplasty procedure
Time Frame: 60 minutes following the placement of the surgical bandage
Two blood samples (5 mL each) will be collected at 60 minutes following the placement of the surgical bandage (n=2 blood collections of a total of 10 mL per patient). When naloxone blood concentrations remain below 1.016-ng/mL, there is not a reduction in opioid analgesia
60 minutes following the placement of the surgical bandage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zetagen Therapeutics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZG-2021-002

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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