[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054042":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":18,"responsibleParty":31,"collaborators":33,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":18,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":18,"enrollmentInfo":46,"targetDuration":18,"studyType":49,"phases":50,"briefSummary":53,"conditions":54,"keywords":18,"overallStatus":56,"whyStopped":18,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":18},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1-Isunakinra treatment Group","EXPERIMENTAL","Study participants randomized to Group 1 treatment group will receive isunakinra at a dose of 50mg SC daily x 24 weeks in addition to standard pembrolizumab-based neoadjuvant chemotherapy (NAC\u002FP).",[13],"Drug: Group 1-Isunakinra",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2-Standard of care treatment group","NO_INTERVENTION","Study participants randomized to Group 2, the control group, will receive standard pembrolizumab-based neoadjuvant chemotherapy (NAC\u002FP).",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Group 1-Isunakinra","isunakinra at a dose of 50mg SC daily x 24 weeks in addition to standard pembrolizumab-based neoadjuvant chemotherapy (NAC\u002FP).",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Michael Reedijk, MD","CONTACT","416-946-4432","Michael.Reedijk@uhn.ca",{"type":32,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[34],{"name":35,"class":36},"Buzzard Pharmaceuticals","INDUSTRY","100054042","phase-1-enhancing-icb-efficacy-through-il-1-inhibition-in-tnbc-100054042",false,"NCT07698106","Enhancing ICB Efficacy Through IL-1 Inhibition in TNBC","Rebooting Sensitivity to Checkpoint Blockade Therapy in Triple-Negative Breast Cancer With Isunakinra (RESETT- I)","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Newly diagnosed, locally advanced, previously untreated and centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines, and staging per current AJCC staging criteria for breast cancer as assessed by the investigator based on radiological and\u002For clinical assessment:\n\n   Clinical stage T1c\u002FN1-N2, T2-4\u002FN0-2\n3. Provides core needle biopsies consisting of at least 2 separate tumor cores from the primary tumor to the central laboratory\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n5. Demonstrates adequate organ function\n6. Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study\n\nExclusion Criteria:\n\n1. Male Gender\n2. Luminal A\u002FB and HER2 positive breast cancer\n3. Multifocal early breast cancer\n4. History of invasive malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer\n5. Received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months\n6. Has received prior therapy with an anti-PD1, anti-PDL1\u002F-PDL2 agent or with an agent directed to another co-inhibitory T-cell receptor\n7. Participated in an interventional clinical study with an investigational compound or device within 4 weeks of randomization for this study\n8. Pre-existing inflammatory arthritis\n9. Has received a live vaccine within 30 days of the first dose of study treatment\n10. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)\n11. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (i.e., dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment\n12. Active or uncontrolled Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C\n13. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis\n14. Has an active infection requiring systemic therapy\n15. Has significant cardiovascular disease\n16. Is pregnant or breastfeeding, or expecting to conceive children within the duration of the study\n17. Has a known history of active tuberculosis (TB, Bacillus Tuberculosis)\n18. Platelets ≤ 100x109\u002FL. ANC ≤ 1.5 x109\u002FL. Hemoglobin ≤ 80 g\u002FL\n19. ECOG≥2\n20. History of stroke or intracranial hemorrhage within 6 months prior to enrollment\n21. Presence of moderate or severe renal function impairment (estimated creatinine clearance \\\u003C60 mL\u002Fmin\u002F1.73m2)\n22. Patients with mild, moderate, or severe hepatic impairment or inadequate liver function (total bilirubin \\> 23 umol\u002FL, serum albumin \\\u003C 35 g\u002FL, INR \\> 1.70)\n23. Known hypersensitivity to E-coli derived proteins, isunakinra or any component of the product","ALL","18 Years",{"count":47,"type":48},60,"ESTIMATED","INTERVENTIONAL",[51,52],"PHASE1","PHASE2","This study is a phase I\u002FII open-label randomized clinical trial to examine whether administration of isunakinra (EBI-005), a modified recombinant IL1 receptor antagonist, can sensitize human TNBC to the PD1 inhibitor-pembrolizumab-based neoadjuvant chemotherapy (NAC\u002FP) by changing the tumor microenvironment (TME) via reducing the recruitment of immunosuppressive tumorassociated macrophages (TAMs) and increasing activated cytotoxic T-lymphocytes (CTLs).",[55],"Triple-Negative Breast Cancer (TNBC)","NOT_YET_RECRUITING","2026-07-06",{"date":59,"type":60},"2026-07-13","ACTUAL",{"date":62,"type":48},"2026-08",{"date":64,"type":48},"2034-08",{"name":5,"class":6}]