Drug:

SV-BR-1-GM (Bria-IMT) in combination with Retifanlimab

Indication:

Breast Cancer, Breast Cancer Metastatic, Breast Neoplasm, End Stage Cancer, Metastatic Breast Cancer, Other advanced solid tumors

Region:

US

Study of the Bria-IMT Regimen and CPI vs Physicians’ Choice in Advanced Metastatic Breast Cancer. (BRIA-ABC )

A Randomized, Open-label Study Comparing the Bria-IMT regimen in combination with Check Point Inhibitor vs Physician’s Choice in Metastatic Breast Cancer

This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor [Retifanlimab], versus Treatment of Patients’/Physicians’ Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.

Experimental:

  • Bria-IMT Regimen + CPI
  • Bria-IMT Regimen Alone

Active Comparator:

  • Treatment of Physician’s Choice

Inclusion Criteria

  • Be ≥ 18 years of age
  • You are being asked to take part in this study because you have recurrent breast cancer that has not responded to traditional treatments
  • Able to travel to one of our clinical sites listed below
  • You will not receive any compensation (payment) for participating in this study. Travel, lodging, and other reasonable expenses may be reimbursed by the sponsor when requested by the study doctor but must be pre-approved by the sponsor

Locations

  • Advent Health – Orlando
    Orlando, Florida, United States, 32804
  • AMR Kansas City Oncology
    Kansas City, Kansas, United States, 66204
  • Care Access-Marrero
    Marrero, Louisiana, United States, 70072
  • The Center for Cancer and Blood Disorders a division of American Oncology Partners, P.A.
    Bethesda, Maryland, United States, 20817
  • Nebraska Cancer Specialists
    Omaha, Nebraska, United States, 68130
  • New York Cancers & Blood Specialists
    Port Jefferson Station, New York, United States, 11776
  • Gabrail Cancer & Research Center
    Canton, Ohio, United States, 44718
  • Texas Oncology-Baylor Charles A. Sammons Cancer Center
    Dallas, Texas, United States, 75246
  • Mary Crowley Cancer Research
    Dallas, Texas, United States, 75251
  • Texas Oncology-San Antonio Cancer Care
    San Antonio, Texas, United States, 78216
  • Tranquil Clinical Research
    Webster, Texas, United States, 77598
  • Hematology-Oncology Associates of Fredericksburg, Inc
    Fredericksburg, Virginia, United States, 22408
  • Cancer Care Northwest
    Spokane Valley, Washington, United States, 99218

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06072612

Study Sponsor: BriaCell Therapeutics Corp.

Sponsor Protocol Number: BC-IMT-04