Recruiting

Phase 1

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

Sponsor:

UCLA

Code:

NCT06205849

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IRE + intratumoral mitazalimab (CD40 antibody) injection

NanoKnife

Study Details

Brief summary:

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

Pancreatic Cancer

Study ID

NCT06205849

Start date

Jul 17, 2024

Status verified date

Jun, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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.

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IRE + CD40 Antibody

Interventions

IRE + intratumoral mitazalimab (CD40 antibody) injection

Surgical IRE will be performed using the NanoKnife System with intraoperative ultrasound guidance via laparotomy under general anesthesia. Mitazalimab (CD40 antibody) will be administered 5 minutes after completion of IRE by slow injection into the center of the ablated zone using a small needle. Core needle biopsies of the tumor will be obtained immediately prior to IRE for identification of candidate tumor antigens. Peripheral blood will be obtained immediately prior to and 12 weeks after the study intervention for analysis of systemic immune effects.

NanoKnife

Non-thermal tumor ablation using short pulses of high voltage electrical current delivered using 19-gauge needles placed via laparotomy using ultrasound guidance

Primary outcome measure

Safety and tolerability [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Shakeela Dad

858-822-5376 sdad@health.ucsd.edu

Locations

UCSD Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

John Bienvenida

(858) 822-4907 jbienvenida@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

Irreversible electroporation (IRE)
NanoKnife
immunotherapy
CD40
Locally advanced pancreatic cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-06-25.