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).
Age > 18 years
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
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
University Health Network, Toronto
Lead sponsor
Buzzard Pharmaceuticals
Collaborator