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NCT06205849 · ClinicalTrials.gov registry record · Phase 1
Intra-tumoral Mitazalimab (CD40 Antibody) With Irreversible Electroporation (IRE) in Locally Advanced Pancreas Cancer
A Phase 1 study of Pancreatic Cancer, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT06205849: Recruiting Phase 1 study of Pancreatic Cancer, sponsored by University of California, San Diego.
NCT06205849 is a Phase 1 study of Pancreatic Cancer that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 18 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06205849, a Phase 1 study of Pancreatic Cancer, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Rates of dose-limiting toxicities (DLTs) and treatment-related adverse events (AEs). AE's will be graded by CTCAE v4, including grading for cytokine release syndrome. A DLT will be defined as any treatment emergent Grade 3 or higher AE that is potentially attributable to mitazalimab or the combination of IRE and mitazalimab. Exceptions will include AE's attributable to normal disease progression.
Conditions Studied
Interventions
- DEVICE NanoKnife
- DRUG IRE + intratumoral mitazalimab (CD40 antibody) injection
Study Locations (1)
California
- UCSD Moores Cancer Center - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-06-25 |
| Est. Completion | 2029-08 |
| Phase | Phase 1 |
What NCT06205849 shows while recruiting
NCT06205849 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Pancreatic Cancer appearing as the primary indexed condition, and to 2 interventions - of which NanoKnife is the first listed.
NCT06205849 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06205849 about?
NCT06205849 is a clinical study titled "Intra-tumoral Mitazalimab (CD40 Antibody) With Irreversible Electroporation (IRE) in Locally Advanced Pancreas Cancer". 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 sid...
What is the current status of trial NCT06205849?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2024-06-25. Estimated completion is 2029-08.
What conditions does trial NCT06205849 study?
This clinical trial studies the following conditions: Pancreatic Cancer.
What interventions are being tested in trial NCT06205849?
The interventions under investigation include: NanoKnife (DEVICE), IRE + intratumoral mitazalimab (CD40 antibody) injection (DRUG).
Who is sponsoring clinical trial NCT06205849?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06205849 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06205849's enrollment target sits among peer trials
18 235th of 278 higher than 38 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
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