Window Study of Intratumoral Mitazalimab in Breast Cancer (WINIT-BC)

The goal of this clinical trial is to study the safety, feasibility, histologic and immunological effects of Mitazalimab, a CD40 agonistic antibody, when administered either alone or in combination with PD-1 inhibition prior to surgical resection. The investigator hypothesizes that preoperative administration of CD40 agonist with or without PD-1 inhibitor intratumorally will demonstrate an acceptable safety profile, will not result in an unplanned delay in surgery, and will lead to increased immune activation. Subjects will receive a single intratumoral dose of CD40 agonist with or without PD-1 inhibitor 7 or more days prior to surgery and will be followed for safety, feasibility, immune, and pathologic responses.

NCT Number	NCT07319195
Lead Sponsor	Jennifer Zhang Collaborators: Alligator Bioscience AB
Conditions	Breast Cancer
Enrollment	32 participants
Start Date	2026-04-27
Primary Completion	2028-04 (estimated)
Study Completion	2033-04 (estimated)
Updated on ClinicalTrials.gov	2026-05-06