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

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: Completed
• Conditions: Metastatic Breast Cancer in the Spine
• Intervention / Treatment: Combination product: ZetaMet™ (ZetaFuse™ Bone Graft)

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: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

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: 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

Outcome Measure	Measure Description	Time Frame
Number of Skeletal Related Events (SREs)	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)	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	Vertebral body defect size measured by planar radiographs	Day 0 to Day 180 postoperatively
Duration of use of postoperative prescription opioid	The average per group duration of intake of opioids in the post-operative setting.	Day 180 postoperatively
Daily dose of postoperative prescription opioid use	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	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	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

• Sponsor: Zetagen Therapeutics, Inc

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): October 10, 2025
• Study Completion (Actual): October 10, 2025

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Metastatic Breast Cancer; Bone Metastases; Spine Metastases; Vancouver; Metastatic Breast Cancer to Bone; X-radiation therapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID 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