Clinical Trials

Our Passion for Patient Care

  • 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.

“We know that bone metastases are common among late-stage cancer patients and the pain associated with them is debiliatating. We look forward to this important next step in development of 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

Our Clinical Trials

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.
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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 study 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.

FAQ

What does a feasibility study investigate?

The primary purpose of a feasibility study 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 study such as how it works in the body, and/or the side effects associated with increased concentration, etc.. A summary of this study is available in infographic format by clicking here.

Who can join this study?

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 the

button above to view in full screen.

Where is this study 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

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:

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