Enhancing ICB Efficacy Through IL-1 Inhibition in TNBC

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).

NCT Number	NCT07698106
Lead Sponsor	University Health Network, Toronto Collaborators: Buzzard Pharmaceuticals
Conditions	Triple-Negative Breast Cancer (TNBC)
Enrollment	60 participants
Start Date	2026-08
Primary Completion	2034-08 (estimated)
Study Completion	2034-08 (estimated)
Updated on ClinicalTrials.gov	2026-07-13