drugset / Trial / NCT07698106
Enhancing ICB Efficacy Through IL-1 Inhibition in TNBC
Phase 1/2
Not yet recruiting
60 enrolled
University Health Network, Toronto
Buzzard Pharmaceuticals · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2026-08
- Primary completion
- 2034-08
- Completion
- 2034-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isunakinra | Unknown | 50 mg | Subcutaneous |