Ten Patient Pilot Study to Evaluate Safety of the ZetaFuse™ Bone Graft Administered Using an Outpatient Local Intratumoral Injection Procedure to Treat Breast Cancer Bone Metastases in the Spine to Control Pain and Prevent Complications Such as Fracture (ZGMBC)

Zetagen Therapeutics

Status: Enrolling

Conditions: Metastatic Breast Cancer in the Spine

Treatments: Device: ZetaFuse™ Bone Graft

Study type: Interventional

Funder types: Industry

Identifiers

NCT05280067

ZG-2021-002

Details and patient eligibility

About

The ZetaFuse™ Bone Graft 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. The ZetaFuse™ Bone Graft is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. The ZetaFuse™ Bone Graft is only for implantation into the vertebral body.

Full 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. The ZetaFuse™ Bone Graft 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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Investigational Device The ZetaFuse™ Bone Graft

Experimental group

Description:

The ZetaFuse™ Bone Graft is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. The ZetaFuse™ Bone Graft is only for implantation into the vertebral body.

Treatment:

Device: ZetaFuse™ Bone Graft