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OncoMatch/Clinical Trials/NCT06205849

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

Is NCT06205849 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including IRE + intratumoral mitazalimab (CD40 antibody) and NanoKnife for pancreatic cancer.

Phase 1RecruitingUniversity of California, San DiegoNCT06205849Data as of May 2026

Treatment: IRE + intratumoral mitazalimab (CD40 antibody) · NanoKnifeThis 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.

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: NCCN-preferred chemotherapy regimen (modified FOLFIRINOX, gemcitabine + albumin-bound paclitaxel, NALIRIFOX)

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)

Cannot have received: CD40 antibody

Prior treatment with a CD40 antibody

Cannot have received: radiation therapy

Exception: to the pancreas

Prior receipt of radiation therapy to the pancreas

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥ 1.5x10^9/L; Platelets ≥ 100x10^9/L; Hemoglobin ≥9 g/dL

Kidney function

Serum creatinine ≤1.5 x ULN OR creatinine clearance ≥40 mL/min (as calculated by Modified Cockcroft-Gault formula)

Liver function

Serum total bilirubin ≤ 1.5 X ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN

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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • UCSD Moores Cancer Center · La Jolla, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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