Jennifer Zhang
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.
Inclusion Criteria: 1. Signed and dated written IRB-approved informed consent. 2. Age ≥18 years. 3. Body weight \> 40kg 4. Stage I-III or recurrent resectable breast cancer to be treated with curative-intent 5. Planning to undergo upfront surgery as part of routine clinical care 6. Discussion with the treating or study medical oncologist re: the potential of sending an Oncotype evaluation (if ER+HER2-) on the core needle biopsy sample 7. Availability of the core needle biopsy sample for correlative studies 8. Surgery to be performed at a University of Pennsylvania Hospital 9. Life expectancy…
Intratumoral agonistic CD40
Checkpoint inhibitor
Arctuva estimate
Verify or correct the compensation shown for this listing.