Ignite Creation Date:
2024-05-06 @ 12:39 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03816163
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2019-01-23
Brief Title:
A Study of Zolbetuximab IMAB362 in Adults With Pancreatic Cancer
Sponsor:
Astellas Pharma Global Development Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase 2 Open-Label Randomized Study to Assess the Efficacy and Safety of Zolbetuximab IMAB362 in Combination With Nab-Paclitaxel and Gemcitabine Nab-P GEM as First Line Treatment in Subjects With Claudin 182 CLDN182 Positive Metastatic Pancreatic Adenocarcinoma
Status:
ACTIVE_NOT_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:
Zolbetuximab is being studied as a treatment for people with pancreatic cancer Most people with pancreatic cancer have a protein called Claudin 182 CLDN182 in their tumor Zolbetuximab is thought to work by attaching to CLDN 182 in their tumor This switches on the bodys 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 studys 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 CLDN182 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 expert panel will check the results and decide the dose to use in Part 2
Part 2 is called the Randomization Phase People will be put in 1 of 2 groups by chance and will be given different treatments either zolbetuximab and chemotherapy or chemotherapy by itself The chance of receiving zolbetuximab and chemotherapy is twice as high as receiving chemotherapy by itself In both parts of the study zolbetuximab and chemotherapy or chemotherapy by itself will be given through a vein This is called an infusion Each treatment cycle is 4 weeks 28 days long and people will have either 2 infusions of zolbetuximab and 3 infusions of chemotherapy or 3 infusions of chemotherapy by itself during each treatment cycle People will visit the clinic on certain days during their treatment The study doctors will check for any medical problems from zolbetuximab Also people in the study will have a health check including blood tests On some visits they will also have scans to check for any changes in their cancer Tumor samples will be taken before treatment if a previous sample is not available People will have the option of giving a tumor sample after treatment has finished People will visit the clinic after they stop treatment They will be asked about any medical problems and will have a health check including blood tests The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not
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 studys 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 CLDN182 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 expert panel will check the results and decide the dose to use in Part 2
Part 2 is called the Randomization Phase People will be put in 1 of 2 groups by chance and will be given different treatments either zolbetuximab and chemotherapy or chemotherapy by itself The chance of receiving zolbetuximab and chemotherapy is twice as high as receiving chemotherapy by itself In both parts of the study zolbetuximab and chemotherapy or chemotherapy by itself will be given through a vein This is called an infusion Each treatment cycle is 4 weeks 28 days long and people will have either 2 infusions of zolbetuximab and 3 infusions of chemotherapy or 3 infusions of chemotherapy by itself during each treatment cycle People will visit the clinic on certain days during their treatment The study doctors will check for any medical problems from zolbetuximab Also people in the study will have a health check including blood tests On some visits they will also have scans to check for any changes in their cancer Tumor samples will be taken before treatment if a previous sample is not available People will have the option of giving a tumor sample after treatment has finished People will visit the clinic after they stop treatment They will be asked about any medical problems and will have a health check including blood tests The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not
Detailed Description:
This study will have a safety lead in phase and a randomization phase
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-002551-15 | EUDRACT_NUMBER | None | None |
| CTR20220914 | REGISTRY | ChinaDrugTrialsorgcn | None |