Actively Recruiting
Intra-tumoral Mitazalimab (CD40 Antibody) With Irreversible Electroporation (IRE) in Locally Advanced Pancreas Cancer
Led by University of California, San Diego · Updated on 2025-07-25
18
Participants Needed
1
Research Sites
266 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
U
University of California, Los Angeles
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intra-tumoral Mitazalimab (CD40 Antibody) With Irreversible Electroporation (IRE) in Locally Advanced Pancreas Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent
- Willingness to comply with all study procedures and availability for the study duration
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma
- Age greater than 18 years
- Locally advanced disease not suitable for surgical removal as defined by specific CT imaging criteria
- ECOG Performance Status of 0 to 2
- Adequate organ function including specified blood counts and kidney and liver function tests
- At least 4 months of chemotherapy with preferred regimens for good performance status
- High-quality imaging within 30 days showing no metastatic disease
- FDG-PET imaging performed to assess tumor activity and metastasis
- Tumor size less than 4.0 cm and suitable for complete ablation
- Use of highly effective contraception for participants able to become pregnant before, during, and after the study
- Use of effective contraception by participants able to cause pregnancy for 1 month after intervention
You will not qualify if you...
- Pregnancy or breastfeeding
- Known allergies to components of mitazalimab solution
- Fever above 38 degrees Celsius within 14 days before intervention
- Treatment with another investigational drug or intervention within 30 days before enrollment
- Previous treatment with a CD40 antibody
- History of severe autoimmune disease
- Presence of metal fiducials or embolization coils in the tumor
- Prior radiation therapy to the pancreas
- Implanted metallic cardiac stimulation devices in the chest
- Uncontrolled cardiac arrhythmias preventing pulse synchronization
- Use of immunosuppressive doses of systemic corticosteroids within 2 weeks before treatment
- Any medical condition preventing major abdominal surgery under general anesthesia
- Presence of distant metastatic disease including positive peritoneal cytology at any time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
Research Team
S
Shakeela Dad
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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