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NCT06396091 · ClinicalTrials.gov registry record · Phase 1
A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer
A Phase 1 study of Metastatic Pancreatic Adenocarcinoma, sponsored by Astellas Pharma Global Development.
- Active
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT06396091: Active Phase 1 study of Metastatic Pancreatic Adenocarcinoma, sponsored by Astellas Pharma Global Development.
NCT06396091 is a Phase 1 study of Metastatic Pancreatic Adenocarcinoma that is active but no longer recruiting, run by Astellas Pharma Global Development. The registered enrollment target is 12 participants, below the 90-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06396091, a Phase 1 study of Metastatic Pancreatic Adenocarcinoma, is active but no longer recruiting, sponsored by Astellas Pharma Global Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer. In this study, zolbetuximab will be given together with chemotherapy to people with pancreatic cancer. Zolbetuximab attaches to a protein called CLDN18.2 found at high levels on the surface of the cancer tumor. This switches on the immune system to attack the tumor. Adults 18 years or older with metastatic pancreatic cancer who have not previously had chemotherapy can take part in the study. There are 2 main aims of this study: * To check the safety of zolbetuximab, when given with chemotherapy in people with metastatic pancreatic cancer * To check if people could cope with (tolerate) any medical problems during the study This is an open-label study. This means people in the study and the study doctors will know that people will receive zolbetuximab with chemotherapy. Different small groups will receive lower to higher doses of zolbetuximab with chemotherapy. Zolbetuximab and chemotherapy will be given through a vein. This is called an infusion. People will receive zolbetuximab on the first day they receive chemotherapy. This will happen every 14 days in a 28-day cycle. People will receive zolbetuximab and chemotherapy in the study clinic and at home. Also, doctors will check for any medical problems. People will also have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer. People will visit the study clinic about 7 days after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests. After this, people will have several more visits to the study clinic for health checks. The number of visits and checks done at each visit will depend on the health of
Primary Outcome
A DLT will be defined as any event meeting the DLT criteria occurring during the DLT assessment period that is related to zolbetuximab.
Conditions Studied
Interventions
- DRUG mFOLFIRINOX
- DRUG zolbetuximab
Study Locations (1)
Washington
- Virginia Mason Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-09-24 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 1 |
What the registry record for NCT06396091 still lists
NCT06396091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 90-participant average among 37 other Metastatic Pancreatic Adenocarcinoma trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Metastatic Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which mFOLFIRINOX is the first listed.
NCT06396091 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT06396091 about?
NCT06396091 is a clinical study titled "A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer". Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer. In this stud...
What is the current status of trial NCT06396091?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2025-09-24. Estimated completion is 2026-07-31.
What conditions does trial NCT06396091 study?
This clinical trial studies the following conditions: Metastatic Pancreatic Adenocarcinoma.
What interventions are being tested in trial NCT06396091?
The interventions under investigation include: mFOLFIRINOX (DRUG), zolbetuximab (DRUG).
Who is sponsoring clinical trial NCT06396091?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06396091 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06396091's enrollment target sits among peer trials
12 36th of 37 higher than 2 of 37 other Metastatic Pancreatic Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Pancreatic Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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