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
Parallel
Group 1-Isunakinra
Drugisunakinra at a dose of 50mg SC daily x 24 weeks in addition to standard pembrolizumab-based neoadjuvant chemotherapy (NAC/P).
Outcome-Study will test whether IL1 blockade can reduce TAM and sensitize human TNBCs to ICB. Outcome measure-changes in the TME induced by the addition of isunakinra to NAC/P will be determined.
The following biomarkers will be evaluated, examining the changes in their expression level between baseline and after 8 weeks of NAC/P ± isunakinra: 1. TAMs 2. Lymphocyte subsets 3. Natural Killer cells 4. Polymorphonuclear myeloid-derived suppressor cells (PMN-MDSCs) 5. Inflammasome expression 6. Cytokines: IL-1β, IL-1α, IL-6, IL-8 and C-reactive protein (CRP)
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University Health Network, Toronto
Lead sponsor
Buzzard Pharmaceuticals
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
