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

Exclusion Criteria

• •1. Metastatic disease.
• •2. Planned neoadjuvant therapy, i.e., not undergoing upfront surgery.
• •3. Known history of hepatitis B or C with active viral replication.
• •4. Administration of any live vaccine within 28 days of first dose of study treatment.
• •5. Prior CD40 or anti-PD-1 agonist therapy.
• •6. Participation in another interventional clinical trial within 30 days before receiving first dose of study treatment. However, the subject may participate in observational studies.
• •7. Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint.
• •8. Current or prior use of immunosuppressive medication within 14 days before study treatment. The following are exceptions to this criterion:
• •1. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
• •2. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
• •9. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
• •10. History of allogenic organ transplantation
• •11. Active or prior documented autoimmune disease. Examples include inflammatory bowel disease \[e.g., colitis or Crohn's disease\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis\], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]. The following are exceptions to this criterion:
• •1. Patients with vitiligo or alopecia
• •2. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or type 1 DM controlled with insulin
• •3. Any chronic skin condition that does not require systemic therapy
• •4. Patients without active autoimmune disease in the last 5 years may be included but only after consultation with the study physician
• •5. Patients with celiac disease controlled by diet alone
• •12. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
• •13. History of another active malignancy except for non-melanoma skin cancer, lentigo maligna or other carcinoma in situ
• •14. History of active primary immunodeficiency
• •15. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
• •16. Body weight \> 110 kg.
• •17. Actively breastfeeding. -