This is a phase I study of an agonistic CD40 antibody (mitazalimab) injected intratumorally at the time of surgical IRE in patients with locally advanced pancreatic cancer. Intratumoral delivery has potential to be more effective than systemic (intravenous) delivery while decreasing the systemic side effects of immunotherapy. We hypothesize that local delivery of mitazalimab at the time of IRE in patients with locally advanced pancreatic cancer will be safe, augment the immune effects of IRE, and decrease the risk of recurrence.
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Histologically/cytologically-confirmed pancreatic ductal adenocarcinoma (PDAC)
Persons, aged > 18 years of age, as PDAC is extremely rare in pediatric populations.
Pregnancy or lactation
Known allergic reactions to components of the mitazalimab solution (L-Histidine, trehalose, or polysorbate 20)
Fever > 38 degrees C within 14 days of study intervention
Treatment with another investigational drug or other intervention within 30 days of enrollment
University of California, San Diego
Lead sponsor
University of California, Los Angeles
Collaborator
National Cancer Institute (NCI)
Collaborator