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RECRUITING Phase 3 ClinicalTrials.gov

Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.

Sponsor: BriaCell Therapeutics Corporation • ClinicalTrials.gov ID: NCT06072612

Registry updated: 2026-09-02
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Description

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.

Interventions

  • SV-BR-1-GM (Biological)
    SV-BR-1-GM is an experimental, allogeneic, whole cell breast tumor cell line stably transfected with the CSF2 gene (encoding GM-CSF) to secrete GM-CSF in vivo to consequently augment dendritic cell activity
  • Cyclophosphamide (Drug)
    Cyclophosphamide is an alkylating agent with indications for treatment of malignant diseases including breast cancer. Cyclophosphamide (Cytoxan) 300 mg/m2 I.V., single dose, will be given to patients assigned to the SV-BR-1-GM. Cyclophosphamide will be administered 2-3 days prior to SV-BR-1-GM inoculations.
  • Interferon infiltration of the inoculation site (Drug)
    Interferon is a cytokine released by cells to regulate immune responses to viral infections. For this study, 0.1 mcg Pegasys per injection site (x 4 injection sites) will be administered.
  • Retifanlimab (Drug)
    Retifanlimab is a checkpoint inhibitor. A total dose of 375mg will be administered at first cycle on or about day +2 (+/-1d). In all other cycles, Retifanlimab is permitted to be administered between Day -2/-3 to Day 2±1 of the cycle based on the convenience of the patients and the clinical sites. However once the timing of the CPI is chosen for C1, it must be given on the same day thereafter throughout the trial.
  • Treatment of Physician's Choice (Drug)
    Patients in the TPC arm of the study will be treated with one or a combination of the following: carboplatin, taxanes, capecitabine, gemcitabine, vinorelbine or eribulin in accordance with the investigators and institutional standard of care. For HER2+ patients, a HER2-targeted agent of the physician's choice can be part of TPC.

Eligibility criteria

Inclusion Criteria: 1. Be ≥ 18 years of age. 2. Have signed informed consent. 3. Have histological confirmation of breast cancer with either locally recurrent unresectable and/or metastatic lesions, and have failed prior therapy: * Patients with persistent disease and local recurrence must not be amenable to local treatment. * For patients with metastatic disease, late-stage MBC with no meaningful alternative therapies available and the following class specific treatment histories: 1. Human epidermal growth factor 2 (HER2) positive must be previously treated with at least 3 regimens containing at least two anti-HER2 and at least one chemotherapy containing regimen. 2. Estrogen receptor (ER), progesterone receptor (PR) positive tumors: must be refractory to hormonal therapy demonstrated by progression on at least 2 hormonal agents in 2 separate lines of hormone directed therapy. 3. Triple Negative tumors: Must have exhausted all curative intent therapies including at least 2 prior chemotherapy regimens, which can include regimens in neoadjuvant and adjuvant settings. 4. Cancers with known germline or genomic actionable targets, e.g. g/mBRCA, must have been treated with all tumor directed indicated treatment e.g. PARPi, if tolerated. 5. HER2 low patients, in addition to the appropriate therapies based on ER/PR status and germline or genomic actionable targets, must also have received at least one HER2-targeted agent approved for treatment of HER2 low patients. 6. HER2 negative tumors must be refractory to hormonal therapy (if indicated) and previously treated with at least 2 chemotherapy regimens. 7. Patients with new or progressive breast cancer metastatic to the brain will be eligible provided: * The brain metastases must be clinically stable (without evidence of progressive disease by imaging for at least 4 weeks prior to first dose) * There is no need for steroids and patients have not had steroids for at least 2 weeks prior to the first dose * Tumor is not impinging on Middle Cerebral Artery/speech-motor strip * If surgically debulked, must be healed with at least 3 weeks since surgery prior to the first dose 4. Has expected survival of at least 4 months. 5. ECOG performance status of 0, 1 or 2 Exclusion Criteria: 1. Concurrent or recent chemotherapy, immunotherapy or major surgery within 21 days prior to the first dose. 2. Radiotherapy within 14 days of the first dose of study treatment. 3. Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of any grade of alopecia and anemia not requiring transfusion support). 4. Any toxicity to prior CPI that was grade 3 or higher unless it has been successfully treated (e.g. hypothyroidism or hypopituitarism treated with replacement therapy), . 5. Toxicity to prior CPI that has not resolved to grade 1 or less except for stable asymptomatic endocrinopathies. 6. History of clinical hypersensitivity to the designated therapy as specified in the protocol, including the proposed TPC, beef, or to any components used in the preparation of SV- BR-1-GM. 7. History of hypersensitivity to any of the therapies proposed for treatment in this study. 8. Serum creatinine OR Measured OR calculated Creatinine Clearance (CrCl) (GFR can also be used in place of creatinine or CrCl) \>2.0 × ULN or \<30 mL/min for participants with creatinine levels \>2.0 × institutional ULN. 9. Absolute granulocyte count \<1000; platelets \<80,000; hemoglobin ≤ 7 g/L. 10. Bilirubin ≥ 2 × ULN unless conjugated bilirubin ≤ ULN; alkaline phosphatase \>5x upper limit of normal (ULN); ALT/AST \>3x ULN. For patients with hepatic metastases, ALT/AST \>5x ULN is exclusionary. 11. INR or PT or aPTT \> 1.8 × ULN, unless the participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants. 12. Receiving any medication listed in the prohibited medication section of the protocol. 13. Proteinuria \>2+ on urinalysis 14. A history or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful. Screening corrected QT interval (QTc) interval \>480 milliseconds is excluded (corrected by Fridericia or Bazett formula). In the event that a single QTc is \>480 milliseconds, the participant may enroll if the average QTc for the 3 ECGs is \<480 milliseconds. 15. New York Heart Association stage 3 or 4 cardiac disease. 16. A pericardial effusion of moderate severity or worse. 17. Symptomatic pleural effusion or ascites. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible. 18. Any woman of childbearing potential (i.e., has had a menstrual cycle within the past year and has not been surgically sterilized), unless she agrees to take appropriate precautions to avoid becoming pregnant during the study and has a negative serum pregnancy test within 7 days prior to starting treatment. 19. Men must have been sterile or, if they were potentially fertile/reproductively competent, should take appropriate precautions to avoid fathering a child for the duration of the study. 20. Women who are pregnant or nursing. 21. Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for \> 1 year, after treatment with curative intent. 22. Patients who have uncontrolled HIV or have clinical or laboratory features indicative of AIDS. 23. Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. 24. Have an active autoimmune disease that has required systemic treatment in past year (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed. 25. Known active HAV, HBV, or HCV infection, as defined by elevated transaminases with the following serology: positivity for HAV IgM antibody, anti-HCV, anti-HBc IgG or IgM, or HBsAg (in the absence of prior immunization). 26. Active infections requiring systemic therapy within the past 14 days. 27. Patients with severe psychiatric disease (e.g., schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the Investigator in consultation with the Medical Monitor. 28. Has received a live vaccine within 28 days of the first dose of study drug. 29. Patients may not be on a concurrent clinical trial, unless approved by the Investigator.

Conditions

Breast Cancer Metastatic Breast Cancer Breast Neoplasm Breast Cancer Metastatic End Stage Cancer

Locations

  • Mayo Clinic-Comprehensive Cancer Center-Breast Clinic — Phoenix, Arizona, United States
  • University of Arizona-Cancer Center — Tucson, Arizona, United States
  • Los Angeles cancer Network_Anaheim — Anaheim, California, United States
  • Comprehensive Blood and Cancer Center — Bakersfield, California, United States
  • Cedars-Sinai Cancer Beverly Hills — Beverly Hills, California, United States
  • Los Angeles Cancer Network_Corona — Corona, California, United States
  • Los Angeles cancer Network_Fountain Vallley — Fountain Valley, California, United States
  • Los Angeles Cancer Network_Glendale — Glendale, California, United States
  • Hoag Hospital Center — Irvine, California, United States
  • Hoag Hospital Irvine — Irvine, California, United States
  • Los Angeles Cancer Network — Los Angeles, California, United States
  • Cedars-Sinai Cancer at Cedars-Sinai Medical Facility — Los Angeles, California, United States
  • Los Angeles Cancer Network_Century City — Los Angeles, California, United States
  • UCLA-Hematology/Oncology Medical Plaza — Los Angeles, California, United States
  • UCLA-Hematology/Oncology_LA 2 — Los Angeles, California, United States
  • UCLA-Hematology/Oncology_LA — Los Angeles, California, United States
  • Los Angeles Cancer Network_Pasadena — Pasadena, California, United States
  • Los Angeles cancer Network_Riverside — Riverside, California, United States
  • UC San Diego — San Diego, California, United States
  • St. John's Cancer Center — Santa Monica, California, United States
  • UCLA-Department of Medicine Hematology/Oncology-Parkside — Santa Monica, California, United States
  • UCLA-Hetamtology/Oncology_S Monica — Santa Monica, California, United States
  • Torrance Memorial Cancer Center — Torrance, California, United States
  • Los Angeles Cancer Network_Valley Pres — Van Nuys, California, United States
  • Cedars-Sinai Breast Health Services Building — West Hollywood, California, United States
  • Smilow Cancer Hospital at Yale New Haven — New Haven, Connecticut, United States
  • University of Miami _SCCC - Aventura — Aventura, Florida, United States
  • University of Miami-SCCC-Lennar — Coral Gables, Florida, United States
  • University of Miami_SCCC-Coral Springs — Coral Springs, Florida, United States
  • University of Miami Hospital and Clinics - Deerfield Beach — Deerfield Beach, Florida, United States
  • University of Miami_SCCC-Hollywood — Hollywood, Florida, United States
  • Mayo Clinic Florida-Comprehensive Cancer Center — Jacksonville, Florida, United States
  • University Of Miami-SCCC-Miami — Miami, Florida, United States
  • University of Miami_SCCC - Kendall — Miami, Florida, United States
  • Advent Health - Orlando — Orlando, Florida, United States
  • University of Miami-SCCC-Plantation — Plantation, Florida, United States
  • Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
  • Northwestern University — Chicago, Illinois, United States
  • Southern Illinois University-Simmons — Springfield, Illinois, United States
  • Carle Foundation Cancer Institute-Urbana — Urbana, Illinois, United States
  • Northwest Cancer Center — Dyer, Indiana, United States
  • AMR Kansas City Oncology — Kansas City, Kansas, United States
  • Care Access-Marrero — Marrero, Louisiana, United States
  • The Center for Cancer and Blood Disorders a division of American Oncology Partners, P.A. — Bethesda, Maryland, United States
  • Mayo Clinic-Comprehensive Cancer Center-Breast Clinic — Rochester, Minnesota, United States
  • Nebraska Cancer Specialists — Omaha, Nebraska, United States
  • Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
  • Hunterdon Medical Center — Flemington, New Jersey, United States
  • New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Babylon) — Babylon, New York, United States
  • NYU Langone's Perlmutter Cancer Center — Manhattan, New York, United States
  • New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(New Hyde Park) — New Hyde Park, New York, United States
  • Manhattan Hematology /Oncology Associates — New York, New York, United States
  • New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (NY) — New York, New York, United States
  • New York Cancers & Blood Specialists_North Shore Hematology Oncology Assocaites P.C (Patchogue) — Patchogue, New York, United States
  • New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Port Jefferson Station2) — Port Jefferson Station, New York, United States
  • New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(Port Jefferson Station1) — Port Jefferson Station, New York, United States
  • New York Cancers & Blood Specialists — Port Jefferson Station, New York, United States
  • New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Riverhead) — Riverhead, New York, United States
  • New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (Brox) — The Bronx, New York, United States
  • Regional Medical Oncology Center_Wlson — Wilson, North Carolina, United States
  • Gabrail Cancer & Research Center — Canton, Ohio, United States
  • Cleveland Clinic — Cleveland, Ohio, United States
  • Texas Oncology-Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
  • Mary Crowley Cancer Research — Dallas, Texas, United States
  • DHR Health Oncology Institute — Edinburg, Texas, United States
  • Texas Oncology - Fredericksburg — Fredericksburg, Texas, United States
  • Texas Oncology - Harlingen — Harlingen, Texas, United States
  • Texas Oncology McAllen — McAllen, Texas, United States
  • Texas Oncology, New Braunfels — New Braunfels, Texas, United States
  • Texas Oncology-San Antonio Cancer Care — San Antonio, Texas, United States
  • Texas Oncology - San Antonio Northeast — San Antonio, Texas, United States
  • Texas Oncology - San Antonio Stone Oak — San Antonio, Texas, United States
  • Tranquil Clinical Research — Webster, Texas, United States
  • Texas Oncology - Weslaco — Weslaco, Texas, United States
  • Hematology-Oncology Associates of Fredericksburg, Inc — Fredericksburg, Virginia, United States
  • Cancer Care Northwest-1 (601 S. Sherman) — Spokane, Washington, United States
  • Cancer Care Northwest_2 (605 E. Holland) — Spokane, Washington, United States
  • Cancer Care Northwest — Spokane Valley, Washington, United States
  • Sheboygan Cancer & Blood Specialists — Sheboygan, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record