Actively Recruiting
Window Study of Intratumoral Mitazalimab in Breast Cancer (WINIT-BC)
Led by Jennifer Zhang · Updated on 2026-05-06
32
Participants Needed
1
Research Sites
361 weeks
Total Duration
On this page
Sponsors
J
Jennifer Zhang
Lead Sponsor
A
Alligator Bioscience AB
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Window Study of Intratumoral Mitazalimab in Breast Cancer (WINIT-BC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated written IRB-approved informed consent
- Age 18 years or older
- Body weight greater than 40 kg
- Stage I-III or recurrent resectable breast cancer planned for curative-intent treatment
- Planning to undergo upfront surgery as part of routine clinical care
- Discussion with treating or study oncologist regarding Oncotype evaluation if ER+HER2-
- Availability of core needle biopsy sample for correlative studies
- Surgery to be performed at University of Pennsylvania Hospital
- Life expectancy of at least 12 weeks
- Adequate bone marrow, liver, and kidney function within 4 weeks prior to study treatment
- ECG with no clinically significant findings
- ECOG performance status 0-1
- Female patients of childbearing potential using effective contraception during and 90 days after treatment
- Able and willing to comply with all study procedures
You will not qualify if you...
- Metastatic disease
- Planned neoadjuvant therapy; not undergoing upfront surgery
- Known active hepatitis B or C infection
- Receipt of any live vaccine within 28 days before first study dose
- Prior treatment with CD40 or anti-PD-1 agonist therapy
- Participation in other interventional trials within 30 days before first study dose
- Any illness or condition affecting safety or study evaluation
- Use of immunosuppressive medication within 14 days before study treatment except specified steroids
- Major surgery within 28 days prior to first investigational product dose
- History of allogenic organ transplantation
- Active or prior autoimmune disease except certain controlled conditions
- Uncontrolled illness including infection, heart failure, hypertension, arrhythmia, lung disease, severe gastrointestinal conditions, or psychiatric/social issues
- History of another active malignancy except specified skin cancers or carcinoma in situ
- History of active primary immunodeficiency
- Known allergy or hypersensitivity to study drugs or excipients
- Body weight over 110 kg
- Actively breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
J
Jennifer Zhang, MD
CONTACT
J
Julia Lewandowski
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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