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

• California Locations
  Irvine, California, United States, 92618
  Hoag Hospital Center
  Hoag Hospital Irvine
• Santa Monica, California, United States, 90404
  John’s Cancer Center
• Florida Locations
  Orlando, Florida, United States, 32804
  Advent Health – Orlando
• Kansas Locations
  Kansas City, Kansas, United States, 66204
  AMR Kansas City Oncology
• Louisiana Locations
  Marrero, Louisiana, United States, 70072
  Care Access-Marrero
• Maryland Locations
  Bethesda, Maryland, United States, 20817
  The Center for Cancer and Blood Disorders a division of American Oncology Partners, P.A.
• Nebraska Locations
  Omaha, Nebraska, United States, 68130
  Nebraska Cancer Specialists
• New York Locations
  Babylon, New York, United States, 11702
  New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Babylon)
  New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (Brox)
  New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(New Hyde Park)
  Manhattan Hematology /Oncology Associates
  New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (NY)
  New York Cancers & Blood Specialists_North Shore Hematology Oncology Associates P.C (Patchogue)
  New York Cancer and Blood Specialists_North Shore Hematology Oncology Associates P.C. (Port Jefferson Station2)

  New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(Port Jefferson Station1)
  New York Cancers & Blood Specialists
  New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Riverhead)
  Gabrail Cancer & Research Center

• Ohio Locations
  Cleveland, Ohio, United States, 44195
  Cleveland Clinic
• Texas Locations
  Dallas, Texas, United States, 75246
  Texas Oncology-Baylor Charles A. Sammons Cancer Center
  Mary Crowley Cancer Research
  Texas Oncology – Fredericksburg
• Harlingen, Texas, United States, 78550
  Texas Oncology – Harlingen
  Texas Oncology McAllen
• New Braunfels, Texas, United States, 78130
  Texas Oncology, New Braunfels
  Texas Oncology-San Antonio Cancer Care
• San Antonio, Texas, United States, 78217
  Texas Oncology – San Antonio Northeast
  Texas Oncology – San Antonio Stone Oak
  Tranquil Clinical Research
• San Antonio, Texas, United States, 78217
  Texas Oncology – San Antonio Northeast
  Texas Oncology – San Antonio Stone Oak
  Tranquil Clinical Research
• Weslaco, Texas, United States, 78596
  Texas Oncology – Weslaco
• Virginia Locations
  Fredericksburg, Virginia, United States, 22408
  Hematology-Oncology Associates of Fredericksburg, Inc
• Spokane Valley, Washington, United States, 99218
  Cancer Care Northwest
• Spokane, Washington, United States, 99202
  Cancer Care Northwest-1 (601 S. Sherman)
• Spokane, Washington, United States, 99218
  Cancer Care Northwest_2 (605 E. Holland)

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