Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205849
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-01-04
Brief Title:
Intra-tumoral Mitazalimab CD40 Antibody With Irreversible Electroporation IRE in Locally Advanced Pancreas Cancer
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Phase 1 Clinical Trial of Intra-tumoral Mitazalimab CD40 Antibody With Irreversible Electroporation IRE in Locally Advanced Pancreas Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Irreversible electroporation IRE is a form of non-thermal ablation tissue destruction that is being used to treat locally advanced pancreatic cancers Locally advanced pancreatic cancers are tumors that have not spread metastasized to distant locations but cannot be surgically resected There is evidence that IRE can help to generate anti-tumor immune responses by releasing tumor antigens in the setting of inflammation CD40 is an immune receptor that helps to stimulate antigen presentation to the immune system Preclinical data from the PIs laboratory have shown that combination of IRE with an antibody that stimulates the CD40 receptor improves responses to IRE and inhibits metastatic tumor growth
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01CA282439 | NIH | None | httpsreporternihgovquickSearch1R01CA282439 |