Study on Bria-IMT Regimen and Checkpoint Inhibitor vs. Doctor's Choice in Advanced Metastatic Breast Cancer

Sponsor: BriaCell Therapeutics Corporation

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06072612

Provider View

This clinical trial is comparing the effectiveness of a new treatment called the Bria-IMT regimen, used with a checkpoint inhibitor, against treatments chosen by doctors for patients with advanced metastatic breast cancer who have no other approved treatment options.

Patient Parameters

Program Overview

The study aims to see if the Bria-IMT regimen, combined with a checkpoint inhibitor called Retifanlimab, can help patients with advanced metastatic or locally recurring breast cancer live longer compared to treatments chosen by their doctors. The study will also look at how well the Bria-IMT regimen works on its own compared to when it's combined with the checkpoint inhibitor.

Description

This study involves patients with advanced metastatic breast cancer who have no other approved treatment options. It will compare three groups: one receiving the Bria-IMT regimen with a checkpoint inhibitor (combination therapy), one receiving treatments chosen by their doctors, and one receiving only the Bria-IMT regimen (monotherapy). After 150 patients join, the monotherapy group will stop, and those patients can switch to the combination therapy if needed.

Patients in the Bria-IMT groups will receive treatment every three weeks, while the doctor's choice group will follow the standard treatment schedule at their location. Patients will continue treatment unless their cancer worsens or they experience major side effects. Imaging tests will be done every six weeks twice, then every eight weeks to monitor progress.

The Bria-IMT regimen includes:

  • Day -2 or -3: Cyclophosphamide 300mg/m2
  • Day 0: SV-BR-1-GM given in four small skin injections
  • Days 1-3: Checkpoint inhibitor infusion and interferon injected into the same sites as the Bria-IMT

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have signed informed consent.
  • Must have confirmed breast cancer that is locally recurrent and cannot be removed by surgery, or has spread to other parts of the body, and have tried previous treatments without success.
    • For HER2 positive cancer: Must have tried at least three treatments, including two anti-HER2 and one chemotherapy.
    • For ER/PR positive cancer: Must have tried at least two hormone therapies without success.
    • For Triple Negative cancer: Must have tried all possible treatments, including two chemotherapy regimens.
    • For cancers with specific genetic targets: Must have tried all indicated treatments, like PARP inhibitors.
    • For HER2 low cancer: Must have tried appropriate therapies based on ER/PR status and at least one HER2-targeted treatment.
    • For HER2 negative cancer: Must have tried hormone therapy (if needed) and at least two chemotherapy regimens.
    • For cancer spread to the brain: Must be stable, not need steroids, and meet specific conditions.
  • Must have an expected survival of at least four months.
  • Must have an ECOG performance status of 0, 1, or 2.

Exclusion Criteria

  • Recent chemotherapy, immunotherapy, or major surgery within 21 days before the first dose.
  • Recent radiotherapy within 14 days before the first dose.
  • Unresolved side effects from previous treatments, except for hair loss and anemia not needing transfusion.
  • Severe side effects from previous checkpoint inhibitors unless successfully treated.
  • Unresolved side effects from previous checkpoint inhibitors, except stable, symptom-free hormone issues.
  • Allergies to the study treatments, including the proposed doctor's choice treatment, beef, or components of SV-BR-1-GM.
  • Allergies to any treatments proposed in this study.
  • High creatinine levels or low kidney function.
  • Low blood cell counts or hemoglobin.
  • High liver enzymes or bilirubin levels.
  • Abnormal blood clotting times unless on stable anticoagulation.
  • Taking prohibited medications.
  • High protein levels in urine.
  • Abnormal ECG that is clinically significant.
  • Severe heart disease or fluid around the heart.
  • Symptomatic fluid around the lungs or abdomen unless stable after treatment.
  • Women of childbearing potential must use birth control and have a negative pregnancy test.
  • Men must be sterile or use birth control.
  • Pregnant or nursing women.
  • Other progressing cancers or recent cancer history, except for certain non-threatening cancers.
  • Uncontrolled HIV or AIDS.
  • Immunodeficiency or recent use of high-dose steroids or immunosuppressive therapy.
  • Active autoimmune disease needing treatment in the past year.
  • Active hepatitis A, B, or C infection.
  • Active infections needing treatment in the past 14 days.
  • Severe psychiatric disorders or major medical problems unless approved by the investigator.
  • Recent live vaccine within 28 days before the first dose.
  • Participation in another clinical trial unless approved by the investigator.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.