NCT05280067

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

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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Zetagen Therapeutics, Inc · Industry
• Sex: Female
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer in the Spine

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-10-10
• Completion: 2025-10-10
• First posted: 2022-03-15
• Last updated: 2026-01-16

Locations

2 sites across 1 country: Canada