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NCT03816163 · ClinicalTrials.gov registry record · Phase 2
A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer
A Phase 2 study of Pancreatic Cancer and Metastatic Pancreatic Adenocarcinoma, sponsored by Astellas Pharma Global Development.
- Active
- Registry status
- Phase 2
- Development phase
- 393
- Enrollment target
- 20
- Study locations
NCT03816163 is a Phase 2 study of Pancreatic Cancer and Metastatic Pancreatic Adenocarcinoma that is active but no longer recruiting, run by Astellas Pharma Global Development. The registered enrollment target is 393 participants, roughly in line with the 392-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target. The trial reports 20 study locations across 11 states.
The verdict
NCT03816163, a Phase 2 study of Pancreatic Cancer and Metastatic Pancreatic Adenocarcinoma, is active but no longer recruiting, sponsored by Astellas Pharma Global Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 393 participants
- Enrollment target
- 20
- Study locations
Study Summary
Zolbetuximab is being studied as a treatment for people with pancreatic cancer. Most people with pancreatic cancer have a protein called Claudin 18.2 (CLDN18.2) in their tumor. Zolbetuximab is thought to work by attaching to CLDN 18.2 in their tumor. This switches on the body's immune system to attack the tumor. Zolbetuximab is a potential treatment for people with pancreatic cancer. There is an unmet medical need to treat people with pancreatic cancer. This study will help find the dose of zolbetuximab to be used with chemotherapy and provide more information on this treatment in adults with metastatic pancreatic cancer. The study is currently ongoing globally. People in this study will be treated with either zolbetuximab and chemotherapy or chemotherapy by itself. The study's main aims are to find a suitable dose of zolbetuximab to be used with chemotherapy in the second part of this study, to check if zolbetuximab and chemotherapy compared to chemotherapy by itself can improve the survival of people with pancreatic cancer, and to check the safety of zolbetuximab when given with chemotherapy and how well people cope with medical problems during the study. Adults with metastatic pancreatic cancer can take part. Their cancer is metastatic, has the CLDN18.2 marker in a tumor sample and has not previously been treated with chemotherapy. Metastatic means the cancer has spread to other parts of the body. People cannot take part are if they have recently had radiotherapy and have not recovered, need to take medicines to suppress their immune system, have history of nervous system metastases from their pancreatic cancer, or they have other active cancers that need treatment. People who have a specific heart condition or infections also cannot take part. This study will be in 2 parts. Part 1 is called the Safety Lead-in Phase. Groups of people will receive 1 of 2 different doses of zolbetuximab: a lower dose or a higher dose, both together with chemotherapy. A medical
Conditions Studied
Interventions
- DRUG nab-paclitaxel
- DRUG gemcitabine
- DRUG zolbetuximab
Study Locations (20)
New York
- Roswell Park Cancer Institute - Buffalo
- Memorial Sloan Kettering Commack - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Northwell Health Cancer Institute - Lake Success
- Memorial Sloan-Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau - Uniondale
California
- St. Joseph Heritage Medical Group - Fullerton
- TOI Clinical research - Whittier
Florida
- Lynn Cancer Institute - Boca Raton
- Baptist Health - Miami
New Jersey
- Memorial Sloan Kettering Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Bergen - Montvale
North Carolina
- Novant Health Presbyterian Medical Center - Charlotte
- Novant Health - Winston-Salem
Connecticut
- Midstate Medical Center - Meriden
Georgia
- Cancer Treatment Centers of Atlanta - Newnan
Illinois
- University of Illinois at Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 393 participants |
| Start Date | 2019-03-15 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03816163
The ClinicalTrials.gov registry entry for NCT03816163 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 393 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 392-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 3 interventions - of which nab-paclitaxel is the first listed.
NCT03816163 reports 20 study locations spanning 11 distinct geographic areas - top geographies include New York, California, Florida.
Frequently Asked Questions
What is clinical trial NCT03816163 about?
NCT03816163 is a clinical study titled "A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer". Zolbetuximab is being studied as a treatment for people with pancreatic cancer. Most people with pancreatic cancer have a protein called Claudin 18.2 (CLDN18.2) in their tumor. Zolbetuximab is thought to work by attaching to CLDN 18.2 in their tumor. This switches on the body's immune system to atta...
What is the current status of trial NCT03816163?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 393 participants. The study started on 2019-03-15. Estimated completion is 2026-08-31.
What conditions does trial NCT03816163 study?
This clinical trial studies the following conditions: Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma, Metastatic Pancreatic Cancer.
What interventions are being tested in trial NCT03816163?
The interventions under investigation include: nab-paclitaxel (DRUG), gemcitabine (DRUG), zolbetuximab (DRUG).
Who is sponsoring clinical trial NCT03816163?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03816163 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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