Enhancing ICB Efficacy Through IL-1 Inhibition in TNBC

Starting soon · Phase 1/Phase 2

Conditions studied: Triple-Negative Breast Cancer (TNBC)

In brief

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).

Key facts

Study ID

NCT07698106

Run by

University Health Network, Toronto

People needed

60

Starts

2026-08-01

Expected to finish

2034-08-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Male Gender
• Luminal A/B and HER2 positive breast cancer
• Multifocal early breast cancer
• 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
• 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
• Participated in an interventional clinical study with an investigational compound or device within 4 weeks of randomization for this study
• Pre-existing inflammatory arthritis
• Has received a live vaccine within 30 days of the first dose of study treatment
• 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)
• 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
• 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
• Is pregnant or breastfeeding, or expecting to conceive children within the duration of the study
• Has a known history of active tuberculosis (TB, Bacillus Tuberculosis)
• Platelets ≤ 100x109/L. ANC ≤ 1.5 x109/L. Hemoglobin ≤ 80 g/L
• ECOG≥2
• History of stroke or intracranial hemorrhage within 6 months prior to enrollment
• 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)
• Known hypersensitivity to E-coli derived proteins, isunakinra or any component of the product

Full record on ClinicalTrials.gov

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