Clinical Trial for Metastatic Breast Cancer to Bone

ZetaMet (Zeta-BC-003) resolves metastatic breast cancer bones lesions suspending cancer, inhibiting pain while regenerating bone, with the potential to increase survival rates.
At Zetagen, we are working on several oncologic drug candidates targeting metastatic and primary cancer for breast, lung, prostate, and bone sarcomas.
With promising clinical data for metastatic breast cancer we are working to use our platform to develop new products to treat other bone and soft tissue tumors.

About the Trial

Zetagen Therapeutics is on a mission to bring forward life-changing therapies to patients suffering from metastatic breast cancer.

This clinical trial is designed for patients like you who have destructive, lytic lesions due to metastatic breast cancer to bone, with or without involvement of other sites. The objective of the trial is to capture early data on the safety and benefit of the ZetaMet™ (Zeta-BC-003) product.

Your doctor has determined you may be a candidate for this study and may benefit from the treatment of metastatic breast cancer lesions to your spine.

ZetaMet™ (Zeta-BC-003) is placed into the vertebral body defect created by metastatic breast cancer, via a well-established outpatient procedure called a vertebroplasty.

The doctor performing the outpatient procedure is Dr. Manraj Heran, the principal investigator for this study. He has extensive experience in performing vertebroplasties and has published several clinical papers on the topic.

Zetagen has received multiple Breakthrough Designations from the US Food and Drug Administration (FDA) and ZetaMet™ (Zeta-BC-003) has been reviewed and approved for Compassionate Use in the United States and for clinical studies in Canada and Australia.

FAQ

What does a feasibility trial investigate?

The primary purpose of a feasibility trial is to capture early data on the safety and benefit of the ZetaMet™ (Zeta-BC-003) drug before it proceeds to further clinical trials. In addition to safety, researchers can answer other questions in a feasibility trial such as how it works in the body, and/or the side effects associated with increased concentration, etc.

Who can join this trial?

Female patients with metastatic breast cancer to bone, with or without involvement of other sites and with at least one lytic metastatic lesion located in a vertebral body of the spine.

Has the ZetaMet™/ ZetaFuse® Bone Graft been used in other patients?

Yes. In the United States, seven (7) patients have already received the product via the FDA’s “Expanded Access/Compassionate Use” program.

Have any patient results been published?

Yes. The first and second Compassionate Use patient’s results have been published in a peer-reviewed medical journal. You may read the publication below.

Click to view publication

Click the

button above to view in full screen.

Where is this trial being conducted?

University of British Columbia (UBC), Vancouver, BC.

Who can I contact about potential enrollment?

Dr. Diego Villa, dvilla@bccancer.bc.ca
and/or
Dr. Manraj Heran, manraj.heran@vch.ca

To be contacted about this Clinical Trial

“We know that bone metastases are common among late-stage cancer patients and the pain associated with them is debiliatating. We are working diligently to develop ZetaMet™ (Zeta-BC-003) which, if successful, will bring this novel therapy one step closer to a reality for patients who need it most.”

- Joe C. Loy, CEO

About ZetaMet™ (Zeta-BC-003)

Presently there is no cure for metastatic breast cancer (MBC) to bone. Lytic lesions from bone metastases from breast, lung, and prostate carcinomas, are associated with a poor prognosis and significant morbidities that include fracture and debilitating pain. A person newly diagnosed with MBC to bone currently has a median overall survival (OS) or life expectancy of approximately nine (9) months. The existing standard of cares (SOC) are palliative and is based upon pain management vs. treating the tumor lesion directly.

ZetaMet™
(Zeta-BC-003)

ZetaMet™ (Zeta-BC-003) was designed to be administered locally without systemic limitations. It is our hope, based upon in-vivo and peer-reviewed published clinical outcomes, that ZetaMet™ (Zeta-BC-003) may assist patients to more effectively manage metastatic spread, reduce pain, and extend life.

ZetaMet™ (Zeta-BC-003), Zetagen’s most advanced drug candidate, is in development to treat metastatic breast cancer to bone. In May 2024, we initiated a feasibility phase 2a clinical trial of ZetaMet™ (Zeta-BC-003) in patients with diagnosed stage IV breast cancer with metastases to the spine (NCT05280067). More information about this trial can be found further down this page.

Our Expanded Access Policy

For information about Zetagen’s Expanded Access Policy, please click here.

Patients and Community Resources

Clinical trials are highly regulated by federal regulatory agencies. You can find additional information at the website of Health Canada.

Additional information can be found in the following websites:

American Cancer Society(ACS)
National Cancer Institute(NCI)
National Comprehensive Cancer Network(NCCN)
ClinicalTrials.Gov