drugset / Trial / NCT06205849
Intra-tumoral Mitazalimab (CD40 Antibody) With Irreversible Electroporation (IRE) in Locally Advanced Pancreas Cancer
Phase 1
Recruiting
18 enrolled
University of California, San Diego
National Cancer Institute (NCI) · collabUniversity of California, Los Angeles · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-07-17
- Primary completion
- 2028-08
- Completion
- 2030-08
Publications
- Background Shankara Narayanan JS, Hayashi T, Erdem S, McArdle S, Tiriac H, Ray P, Pu M, Mikulski Z, Miller A, Messer K, Carson D, Schoenberger S, White RR. Treatment of pancreatic cancer with irreversible electroporation and intratumoral CD40 antibody stimulates systemic immune responses that inhibit liver metastasis in an orthotopic model. J Immunother Cancer. 2023 Jan;11(1):e006133. doi: 10.1136/jitc-2022-006133.
- Background Irenaeus SMM, Nielsen D, Ellmark P, Yachnin J, Deronic A, Nilsson A, Norlen P, Veitonmaki N, Wennersten CS, Ullenhag GJ. First-in-human study with intratumoral administration of a CD40 agonistic antibody, ADC-1013, in advanced solid malignancies. Int J Cancer. 2019 Sep 1;145(5):1189-1199. doi: 10.1002/ijc.32141. Epub 2019 Mar 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mitazalimab | Monoclonal antibody | 25 ug/kg | Other |
| Subject | Mitazalimab | Monoclonal antibody | 75 ug/kg | Other |
| Subject | Mitazalimab | Monoclonal antibody | 200 ug/kg | Other |