Back to search results

Study of Mitazalimab and IRE for Pancreatic Cancer

This study is looking at a new way to treat locally advanced pancreatic cancer, which is cancer that hasn't spread but can't be removed by surgery. It combines a procedure called Irreversible Electroporation (IRE), which uses electrical pulses to destroy cancer cells, with an immunotherapy drug called mitazalimab. The mitazalimab is injected directly into the tumor after IRE. Researchers hope this local delivery will be safer and more effective than giving the drug through an IV. The main goal is to see if this combination is safe and well-tolerated. You may be able to join if you are over 18 and have pancreatic cancer confirmed by a biopsy. This study plans to enroll 18 participants.

Study design
This is a Phase 1 study, which means it's an early study to check safety. It plans to enroll 18 participants.
What's involved
You would need to provide signed consent and be available for the study duration. The intervention involves surgical IRE and an injection of mitazalimab.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be measured at 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06205849

Intra-tumoral Mitazalimab (CD40 Antibody) With Irreversible Electroporation (IRE) in Locally Advanced Pancreas Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of California, San Diego
~18 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:IRE + intratumoral mitazalimab (CD40 antibody) injectionNanoKnife

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability
Measured over 12 weeks

Conditions

Pancreatic Cancer

Explore related trials

Pancreatic Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Rebekah R White, MD · PRINCIPAL_INVESTIGATOR · University of California, San Diego

Who to contact

Shakeela Dad
[email protected]
858-822-5376
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.
Locally advanced disease that is not amenable to surgical resection. Locally advanced PDAC cases will be identified per the definition developed by the Alliance for Clinical Trials in Oncology\[53\]. Per this definition, locally advanced PDAC is defined as presence of any one or more of the following on CT:
Occlusion of the superior mesenteric vein (SMV) and/or portal vein (PV) that is not amenable to resection and venous reconstruction
Interface between tumor and hepatic artery that is not amenable to resection and reconstruction
Interface between the tumor and superior mesenteric artery (SMA) measuring \> 180º of the circumference of the vessel wall
Interface between the tumor and celiac axis measuring \> 180º of the circumference of the vessel wall that is not amenable to resection
ECOG Performance Status of 0-2
Have adequate organ function per criteria below:
Absolute neutrophil count (ANC) ≥ 1.5x109/L
Platelets ≥ 100x109/L
Hemoglobin ≥9 g/dL
Serum creatinine ≤1.5 x ULN OR creatinine clearance ≥40 mL/min (as calculated by Modified Cockcroft-Gault formula)
Serum total bilirubin ≤ 1.5 X ULN
AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN
A minimum of 4 months of one of the chemotherapy regimens preferred by the NCCN for good performance status patients (currently modified FOLFIRINOX, gemcitabine + albumin-bound paclitaxel, or NALIRIFOX)
High quality imaging triphasic CT scan contrast-enhanced dynamic MRI of abdomen and either contrast-enhanced or non-contrast CT of chest and pelvis that demonstrate no evidence of metastatic disease within 30 days of enrollment
FDG-PET imaging (skullbase-midthigh) at any timepoint between diagnosis and study intervention to determine whether tumor is PET-avid and evaluate for extra-pancreatic metastatic disease, as suggested by NCCN guidelines for high-risk patients.
Tumor amenable to "in situ" (complete) ablation with maximum primary tumor dimension \< 4.0 cm
For participants able to become pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method until the study intervention and for an additional 1 month after the study intervention.
For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner for 1 month after study intervention.

Exclusion

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
Prior treatment with a CD40 antibody
History of severe auto-immune disease
The presence of metal fiducials or embolization coils within the tumor.
Prior receipt of radiation therapy to the pancreas
The presence of implanted metallic cardiac stimulation devices within the chest
Uncontrolled cardiac arrhythmias that prevent synchronization of pulse delivery with the refractory period of the cardiac cycle
Immunosuppressive doses of systemic medications, such as corticosteroids or absorbed topical corticosteroids (doses \> 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks (14 days) before study treatment administration. Physiologic doses of corticosteroids (≤ 10 mg/day of prednisone or its equivalent) or short pulses of corticosteroids (≤ 3 days) may be permitted.
Any medical condition that precludes major abdominal surgery under general anesthesia
Presence of distant metastatic disease (including positive peritoneal cytology) on staging laparoscopy and/or exploratory laparotomy at any timepoint.

What this trial measures

  • Safety and tolerability12 weeks

    Rates of dose-limiting toxicities (DLTs) and treatment-related adverse events (AEs). AE's will be graded by CTCAE v4, including grading for cytokine release syndrome. A DLT will be defined as any treatment emergent Grade 3 or higher AE that is potentially attributable to mitazalimab or the combination of IRE and mitazalimab. Exceptions will include AE's attributable to normal disease progression.