Isunakinra added to immunotherapy and chemotherapy for triple-negative breast cancer
Tests isunakinra alongside pembrolizumab-based chemotherapy in adults with triple-negative breast cancer.
Plain-language title generated from the registry record
Registry title: Enhancing ICB Efficacy Through IL-1 Inhibition in TNBC
Key facts
- Where
- Toronto, CanadaSee the site
- Phase
- Phase 1/2
Where in Canada
- Princess Margaret Cancer CentreToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Health Network, Toronto
- Trial code
- NCT07698106
- Record updated
- 29 October 2026
- Original description
This study is a phase I/II 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/P) by changing the tumor microenvironment (TME) via reducing the recruitment of immunosuppressive tumorassociated macrophages (TAMs) and increasing activated cytotoxic T-lymphocytes (CTLs).Read full original descriptionShow less
Rebooting Sensitivity to Checkpoint Blockade Therapy in Triple-Negative Breast Cancer With Isunakinra (RESETT- I)
This study is a phase I/II 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/P) by changing the tumor microenvironment (TME) via reducing the recruitment of immunosuppressive tumorassociated macrophages (TAMs) and increasing activated cytotoxic T-lymphocytes (CTLs).
Inclusion: Age > 18 years; Newly diagnosed, locally advanced, previously untreated and centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, and staging per current AJCC staging criteria for breast cancer as assessed by the investigator based on radiological and/or clinical assessment:; Clinical stage T1c/N1-N2, T2-4/N0-2; Provides core needle biopsies consisting of at least 2 separate tumor cores from the primary tumor to the central laboratory; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Demonstrates adequate organ function; Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study.
Exclusion: Received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months; Has received prior therapy with an anti-PD1, anti-PDL1/-PDL2 agent or with an agent directed to another co-inhibitory T-cell receptor; Has received a live vaccine within 30 days of the first dose of study treatment; 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; History of stroke or intracranial hemorrhage within 6 months prior to enrollment; Luminal A/B and HER2 positive breast cancer; Multifocal early breast cancer; 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); Active or uncontrolled Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C; Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis; Has an active infection requiring systemic therapy; Has significant cardiovascular disease; Has a known history of active tuberculosis (TB, Bacillus Tuberculosis); Known hypersensitivity to E-coli derived proteins, isunakinra or any component of the product; Platelets ≤ 100x109/L. ANC ≤ 1.5 x109/L. Hemoglobin ≤ 80 g/L; Presence of moderate or severe renal function impairment (estimated creatinine clearance <60 mL/min/1.73m2); Patients with mild, moderate, or severe hepatic impairment or inadequate liver function (total bilirubin > 23 umol/L, serum albumin < 35 g/L, INR > 1.70); 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; Male Gender; Participated in an interventional clinical study with an investigational compound or device within 4 weeks of randomization for this study; Pre-existing inflammatory arthritis; Is pregnant or breastfeeding, or expecting to conceive children within the duration of the study; ECOG≥2.