Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396091
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-04-30
Brief Title:
A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer
Sponsor:
Astellas Pharma Global Development Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase 1 Open-label Study to Assess the Safety and Tolerability of Zolbetuximab IMAB362 in Combination With Chemotherapy mFOLFIRINOX in Participants With CLDN182 Positive Metastatic Pancreatic Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT06048081
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief 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 CLDN182 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 each person and whether they complete their treatment or not
In this study zolbetuximab will be given together with chemotherapy to people with pancreatic cancer Zolbetuximab attaches to a protein called CLDN182 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 each person and whether they complete their treatment or not
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None