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 P

Trial Details

NCT ID

NCT07319195

Phase

EARLY_PHASE1

Sponsor

Jennifer Zhang

Status

RECRUITING

Cancer Type

Breast Cancer

Interventions

• Intratumoral Mitazalimab
• Intratumoral Nivolumab

Locations (sample)

• Philadelphia, Pennsylvania, United States|39.95238,-75.16362

Key Eligibility Criteria

• Signed and dated written IRB-approved informed consent.
• Age ≥18 years.
• Body weight \> 40kg
• Stage I-III or recurrent resectable breast cancer to be treated with curative-intent

For full eligibility, visit ClinicalTrials.gov.

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