NCT07319195

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

Window of Opportunity Study of Intratumoral CD40 Agonist (Mitazalimab) With or Without PD-1 Inhibitor (Nivolumab) in Patients With Resectable Breast Cancer (WINIT-BC)

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Jennifer Zhang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Intratumoral Mitazalimab	Intratumoral agonistic CD40
DRUG	Intratumoral Nivolumab	Checkpoint inhibitor

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2033-03-01
• First posted: 2026-01-06
• Last updated: 2026-02-18

Regulatory

• FDA-regulated drug study