Ignite Creation Date:
2024-05-06 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05365581
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2022-05-05
Brief Title:
A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer Gastroesophageal Junction Cancer or Pancreatic Cancer
Sponsor:
Astellas Pharma Global Development Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase 11b Study of ASP2138 as Monotherapy and in Combination With Pembrolizumab and mFOLFOX6 or Ramucirumab and Paclitaxel in Participants With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction GEJ Adenocarcinoma and in Combination With mFOLFIRINOX in Participants With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Whose Tumors Have Claudin CLDN 182 Expression
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Claudin 182 protein or CLDN182 is a protein found on cells in the digestive system It is also found on some tumors Researchers are looking at ways to attack CLDN182 to help control tumors ASP2138 is thought to bind to CLDN182 and a protein called on a type of immune cell called a T-cell This tells the immune system to attack the tumor
ASP2138 is a potential treatment for people with stomach cancer gastroesophageal junction cancer GEJ cancer or pancreatic cancer GEJ is where the tube that carries food esophagus joins the stomach Before ASP2138 is available as a treatment the researchers need to understand how it is processed by and acts upon the body In this study ASP2138 will either be given by itself or given together with standard treatments for gastric GEJ and pancreatic cancer Pembrolizumab and mFOLFOX6 modified leucovorin folinic acid 5-FU fluorouracil and oxaliplatin and ramucirumab and paclitaxel are standard treatments for gastric and GEJ cancer mFOLFIRINOX modified leucovorin folinic acid 5-FU fluorouracil irinotecan and oxaliplatin is a standard treatment for pancreatic cancer This information will help to find a suitable dose of ASP2138 given by itself and together with the standard cancer treatments and to check for potential medical problems from the treatments
Adults 18 years or older with stomach cancer GEJ cancer or pancreatic cancer can take part Their cancer is locally advanced unresectable or metastatic Locally advanced means the cancer has spread to nearby tissue Unresectable means the cancer cannot be removed by surgery Metastatic means the cancer has spread to other parts of the body
The main aims of the study are to check the safety of ASP2138 and how well people cope with tolerate any medical problems during the study and to find a suitable dose of ASP2138 to be used later in this study These are done for ASP2138 given by itself and when given together with the standard cancer treatments
The study will have 2 phases In phase 1 different small groups of people will receive lower to higher doses of ASP2138 given by itself or together with the standard cancer treatments Any medical problems will be recorded at each dose This is done to find suitable doses of ASP2138 to use later in the study Doctors will also check how each type of cancer responds to ASP2138 In phase 1b other different small groups will receive suitable doses of ASP2138 given by itself or together with the standard cancer treatments Suitable doses will be found from phase 1 Phase 1b will check how each type of cancer responds to ASP2138 given by itself or together with the standard cancer treatments The response to ASP2138 is measured using scans and blood tests Safety checks will be done at each visit and the doctors will continue to check for all medical problems throughout the study
ASP2138 will be given either through a vein intravenous infusion or just below the skin subcutaneous injection Treatment will be in a 14-day cycle 2 weeks In each treatment cycle intravenous infusions or subcutaneous injections will either be given once a week or once every 2 weeks
People will continue to receive treatment until their cancer gets worse or the doctor decides to stop the persons treatment People will visit the clinic on certain days during their treatment with extra visits during the first 3 cycles of treatment
After treatment has finished people will visit the clinic for a health check several times 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
ASP2138 is a potential treatment for people with stomach cancer gastroesophageal junction cancer GEJ cancer or pancreatic cancer GEJ is where the tube that carries food esophagus joins the stomach Before ASP2138 is available as a treatment the researchers need to understand how it is processed by and acts upon the body In this study ASP2138 will either be given by itself or given together with standard treatments for gastric GEJ and pancreatic cancer Pembrolizumab and mFOLFOX6 modified leucovorin folinic acid 5-FU fluorouracil and oxaliplatin and ramucirumab and paclitaxel are standard treatments for gastric and GEJ cancer mFOLFIRINOX modified leucovorin folinic acid 5-FU fluorouracil irinotecan and oxaliplatin is a standard treatment for pancreatic cancer This information will help to find a suitable dose of ASP2138 given by itself and together with the standard cancer treatments and to check for potential medical problems from the treatments
Adults 18 years or older with stomach cancer GEJ cancer or pancreatic cancer can take part Their cancer is locally advanced unresectable or metastatic Locally advanced means the cancer has spread to nearby tissue Unresectable means the cancer cannot be removed by surgery Metastatic means the cancer has spread to other parts of the body
The main aims of the study are to check the safety of ASP2138 and how well people cope with tolerate any medical problems during the study and to find a suitable dose of ASP2138 to be used later in this study These are done for ASP2138 given by itself and when given together with the standard cancer treatments
The study will have 2 phases In phase 1 different small groups of people will receive lower to higher doses of ASP2138 given by itself or together with the standard cancer treatments Any medical problems will be recorded at each dose This is done to find suitable doses of ASP2138 to use later in the study Doctors will also check how each type of cancer responds to ASP2138 In phase 1b other different small groups will receive suitable doses of ASP2138 given by itself or together with the standard cancer treatments Suitable doses will be found from phase 1 Phase 1b will check how each type of cancer responds to ASP2138 given by itself or together with the standard cancer treatments The response to ASP2138 is measured using scans and blood tests Safety checks will be done at each visit and the doctors will continue to check for all medical problems throughout the study
ASP2138 will be given either through a vein intravenous infusion or just below the skin subcutaneous injection Treatment will be in a 14-day cycle 2 weeks In each treatment cycle intravenous infusions or subcutaneous injections will either be given once a week or once every 2 weeks
People will continue to receive treatment until their cancer gets worse or the doctor decides to stop the persons treatment People will visit the clinic on certain days during their treatment with extra visits during the first 3 cycles of treatment
After treatment has finished people will visit the clinic for a health check several times 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:
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| jRCT2031210644 | REGISTRY | jRCT | None |
| CTR20241945 | REGISTRY | None | None |