Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-31 @ 3:08 PM
Study NCT ID:
NCT05280067
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-20
First Post:
2022-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ZETAMET™ BONE GRAFT IN THE REPAIR OF BONE DEFECTS FROM METASTATIC BREAST CANCER IN VERTEBRAL BONES
Sponsor:
Zetagen Therapeutics, Inc
Organization:
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZGMBC
Brief Summary:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: