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

PHASE1RecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

June 25, 2024

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2029

Conditions
Pancreatic Cancer
Interventions
DRUG

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.

DEVICE

NanoKnife

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

Trial Locations (1)

92093

RECRUITING

UCSD Moores Cancer Center, La Jolla

All Listed Sponsors
collaborator

University of California, Los Angeles

OTHER

collaborator

National Cancer Institute (NCI)

NIH

lead

University of California, San Diego

OTHER