[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BriaCell Therapeutics Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100521670","phase-3-study-of-the-bria-imt-regimen-and-cpi-vs-physicians-choice-in-advanced-metastatic-breast-cancer-100521670",false,"NCT06072612","Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.","Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor vs Physicians' Choice in Advanced Metastatic Breast Cancer.","BRIA-ABC","Inclusion Criteria:\n\n1. Be ≥ 18 years of age.\n2. Have signed informed consent.\n3. Have histological confirmation of breast cancer with either locally recurrent unresectable and\u002For metastatic lesions, and have failed prior therapy:\n\n   * Patients with persistent disease and local recurrence must not be amenable to local treatment.\n   * For patients with metastatic disease, late-stage MBC with no meaningful alternative therapies available and the following class specific treatment histories:\n\n     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.\n     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.\n     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.\n     4. Cancers with known germline or genomic actionable targets, e.g. g\u002FmBRCA, must have been treated with all tumor directed indicated treatment e.g. PARPi, if tolerated.\n     5. HER2 low patients, in addition to the appropriate therapies based on ER\u002FPR status and germline or genomic actionable targets, must also have received at least one HER2-targeted agent approved for treatment of HER2 low patients.\n     6. HER2 negative tumors must be refractory to hormonal therapy (if indicated) and previously treated with at least 2 chemotherapy regimens.\n     7. Patients with new or progressive breast cancer metastatic to the brain will be eligible provided:\n\n        * The brain metastases must be clinically stable (without evidence of progressive disease by imaging for at least 4 weeks prior to first dose)\n        * There is no need for steroids and patients have not had steroids for at least 2 weeks prior to the first dose\n        * Tumor is not impinging on Middle Cerebral Artery\u002Fspeech-motor strip\n        * If surgically debulked, must be healed with at least 3 weeks since surgery prior to the first dose\n4. Has expected survival of at least 4 months.\n5. ECOG performance status of 0, 1 or 2\n\nExclusion Criteria:\n\n1. Concurrent or recent chemotherapy, immunotherapy or major surgery within 21 days prior to the first dose.\n2. Radiotherapy within 14 days of the first dose of study treatment.\n3. 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).\n4. 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), .\n5. Toxicity to prior CPI that has not resolved to grade 1 or less except for stable asymptomatic endocrinopathies.\n6. 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.\n7. History of hypersensitivity to any of the therapies proposed for treatment in this study.\n8. Serum creatinine OR Measured OR calculated Creatinine Clearance (CrCl) (GFR can also be used in place of creatinine or CrCl) \\>2.0 × ULN or \\\u003C30 mL\u002Fmin for participants with creatinine levels \\>2.0 × institutional ULN.\n9. Absolute granulocyte count \\\u003C1000; platelets \\\u003C80,000; hemoglobin ≤ 7 g\u002FL.\n10. Bilirubin ≥ 2 × ULN unless conjugated bilirubin ≤ ULN; alkaline phosphatase \\>5x upper limit of normal (ULN); ALT\u002FAST \\>3x ULN. For patients with hepatic metastases, ALT\u002FAST \\>5x ULN is exclusionary.\n11. 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.\n12. Receiving any medication listed in the prohibited medication section of the protocol.\n13. Proteinuria \\>2+ on urinalysis\n14. 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 \\\u003C480 milliseconds.\n15. New York Heart Association stage 3 or 4 cardiac disease.\n16. A pericardial effusion of moderate severity or worse.\n17. Symptomatic pleural effusion or ascites. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.\n18. 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.\n19. Men must have been sterile or, if they were potentially fertile\u002Freproductively competent, should take appropriate precautions to avoid fathering a child for the duration of the study.\n20. Women who are pregnant or nursing.\n21. 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.\n22. Patients who have uncontrolled HIV or have clinical or laboratory features indicative of AIDS.\n23. 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.\n24. 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.\n25. 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).\n26. Active infections requiring systemic therapy within the past 14 days.\n27. 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.\n28. Has received a live vaccine within 28 days of the first dose of study drug.\n29. Patients may not be on a concurrent clinical trial, unless approved by the Investigator.","ALL","18 Years",{"count":20,"type":21},404,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","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'\u002FPhysicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.",[27,28,29,30,31],"Breast Cancer","Metastatic Breast Cancer","Breast Neoplasm","Breast Cancer Metastatic","End Stage Cancer",[33,34,35,36,37],"Breast","metastatic","advanced","cancer","late line","RECRUITING","2026-04-06",{"date":41,"type":42},"2026-04-07","ACTUAL",{"date":44,"type":42},"2023-12-05",{"date":46,"type":21},"2028-06",{"name":48,"class":49},"BriaCell Therapeutics Corporation","INDUSTRY",79,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100552329","phase-1-a-study-of-bria-ots-cellular-immunotherapy-in-metastatic-recurrent-breast-cancer-100552329","NCT06471673","A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer","Key Inclusion Criteria:\n\n1. Histological confirmed recurrent metastatic breast cancer which has failed prior\n\n   therapy defined as:\n   1. Human epidermal growth factor 2 (EGFR2, HER2) positive tumors must have failed therapy with at least 2 anti-HER2 agents\n   2. HER2 negative and either ER or PR positive tumors: must be refractory to hormonal therapy and previously treated with at least 2 hormone based targeted therapy containing regimens.\n   3. Triple-negative and inflammatory tumors must have exhausted other curative intent therapies including prior treatment with a taxane and platinum-based agent\n   4. All other MBC types must have exhausted other curative intent therapies including any genomic or germline directed targeted therapy having available approved drug(s)\n   5. Patients with new or progressive breast cancer metastatic to the brain will be eligible, provided:\n\n   i. The brain metastases must be clinically stable (without evidence of progressive disease by imaging) for at least 4 weeks, prior to first dose.\n\n   ii. There is no need for steroids and patients have not had steroids for at least 2 weeks prior to the first dose.\n2. Be 18 years of age or older.\n3. Have expected survival of at least 4 months.\n4. Have adequate performance status (up to and including ECOG 2)\n5. Patients must be stable with all known or expected toxicities from previous treatment including:\n\n   1. Prior immune related toxicity must not have exceeded Grade 2 with exception of stable endocrinopathy (endocrinopathy if well-managed, is not exclusionary).\n   2. Toxicity of prior therapy that has not recovered to ≤ grade 1 or baseline (with the exception of any grade of alopecia, adequately treated endocrinopathy, and anemia not requiring transfusion support).\n\nExclusion Criteria:\n\n1. Concurrent anti-cancer treatment.\n2. Recent chemotherapy, radiotherapy, or other anti-cancer treatment within 3 weeks of first protocol treatment.\n3. Participant has not recovered adequately from toxicities and\u002For complications from surgical intervention before starting study drug.\n4. History of clinical hypersensitivity to the designated therapy, as specified in the protocol or to any components used in the preparation of any cell line in this study.\n5. History of clinical hypersensitivity to any protocol specified therapy.\n6. BUN \\>30 in conjunction with a creatinine \\>2, or calculated creatinine clearance (CrCl) \\\u003C30 mL\u002Fmin (GFR can be used in place of creatinine or CrCl).\n7. Absolute granulocyte count \\\u003C 1000; platelets \\\u003C50,000.\n8. Bilirubin \\>2.0; alkaline phosphatase \\>4x upper limit of normal (ULN); ALT\u002FAST \\>2x ULN. For patients with hepatic metastases, ALT\u002FAST \\>5x ULN is exclusionary.\n9. Proteinuria \\>1+ on urinalysis or \\>1 gm\u002F24hr.\n10. New York Heart Association stage 3 or 4 cardiac disease.\n11. A pleural or pericardial effusion of moderate severity or worse.\n12. 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.\n13. Men who are fertile\u002Freproductively competent, should take appropriate precautions to avoid fathering a child for the duration of the study.\n14. Women who are pregnant or nursing.\n15. Patients with concurrent second malignancy.\n16. Persons with previous malignancies requiring treatment within the past 24 months.\n17. Patients who have clinical or laboratory features indicative of AIDS and are HIV positive (by self-report).\n18. 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 21 days prior to first dose of study treatment.\n19. Patients who are on treatment for an autoimmune disease, unless specifically approved by the Investigator and the Sponsor.\n20. Patients with severe psychiatric (e.g., schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the Investigator and Sponsor.\n21. Patients may not be on a concurrent clinical trial, unless approved by Investigator and Sponsor.",{"count":58,"type":21},18,[60,61],"PHASE1","PHASE2","This is an open-label Phase 1\u002F2a study. Once the safety of the BC1 cell line alone has been demonstrated in Phase 1, in Phase 2, patients will be treated with the Bria-OTS regimen (see below) and a clinically available check point inhibitor (CPI).\n\nDuring the monotherapy phase of Phase 1, one patient will be treated intradermally every 2 weeks for 6 weeks (4 doses) with an initial dose of the BC1 cell line. If this dose is tolerated, the next patient will receive an increased dose of BC1. If once again tolerated, the third patient will receive a further dose increase of the BC1. Once at least 3 patients have been safely treated with the BC1 cell line, with no dose-limiting toxicity (DLT), the combinational phase of the study will commence.\n\nFollowing the monotherapy phase, patients will be treated with BC1 and the Bria-OTS regimen (see below) every 3 weeks, plus a CPI at the FDA approved labelled dose and schedule. There will be at least a 2-week spacing between enrollment of each of the first three subjects in the study in order to assess for any early unanticipated risk(s).\n\nDuring the Phase 1 combination and Phase 2 expansion phases, all patients will be treated with BC1 cells as part of the Bria-OTS regimen, which includes cyclophosphamide 300 mg\u002Fm2 2-3 days prior to BC1 cell inoculation, and peginterferon alpha-2a administered on the same day, following BC1 cell inoculation.",[27,64,65,66,67,68],"Breast Tumor","Cancer of Breast","Cancer of the Breast","Malignant Tumor of Breast","Tumors, Breast","2024-08-23",{"date":71,"type":42},"2024-08-26",{"date":73,"type":42},"2024-05-29",{"date":75,"type":21},"2025-10-30",{"name":48,"class":49},1,""]