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NCT05365581 · ClinicalTrials.gov registry record · Phase 1
A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer
A Phase 1 study of Pancreatic Adenocarcinoma and Gastric Adenocarcinoma, sponsored by Astellas Pharma Global Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 398
- Enrollment target
- 20
- Study locations
NCT05365581 is a Phase 1 study of Pancreatic Adenocarcinoma and Gastric Adenocarcinoma that is actively recruiting participants, run by Astellas Pharma Global Development. The registered enrollment target is 398 participants, below the 99,459-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 16 states.
The verdict
NCT05365581, a Phase 1 study of Pancreatic Adenocarcinoma and Gastric Adenocarcinoma, is actively recruiting participants, sponsored by Astellas Pharma Global Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 398 participants
- Enrollment target
- 20
- Study locations
Study Summary
Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to CLDN18.2 and a protein 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, and ramucirumab and paclitaxel are standard treatments for gastric and GEJ cancer. mFOLFIRINOX is a standard treatment for pancreatic cancer. This information will help 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. The main aims of the study are: * To check the safety of ASP2138 and how well people can tolerate medical problems during the study. * To find a suitable dose of ASP2138 to be used later in the study. * These are done for ASP2138 given by itself and when given together with the standard cancer 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. There should also be the CLDN18.2 marker in a tumor sample. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding i
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG ASP2138
Study Locations (20)
New York
- NYU Langone Medical Center - NYU Medical Oncology Associates - New York
- Columbia University - New York
- Memorial Sloan Kettering Cancer Center - New York
California
- University of California Irvine Medical Center - Orange
- UCLA Dept of Medicine - Hematology/Oncology, Santa Monica - Santa Monica
North Carolina
- Duke Children's Hospital and Health Center - Durham
- Wake Forest University Baptist Health - Winston-Salem
Illinois
- Northwestern University - Chicago
Kansas
- University of Kansas Cancer Center - Westwood
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Texas
- UT Southwestern Medical Center - Dallas
Washington
- Virginia Mason Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 398 participants |
| Start Date | 2022-06-07 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05365581
The ClinicalTrials.gov registry entry for NCT05365581 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 398 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 99,459-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower). 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 Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT05365581 reports 20 study locations spanning 16 distinct geographic areas - top geographies include New York, California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05365581 about?
NCT05365581 is a clinical study titled "A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer". Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to CLDN18.2 and a protein on a type of immune cell called a T-cell. This "tell...
What is the current status of trial NCT05365581?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 398 participants. The study started on 2022-06-07. Estimated completion is 2027-05-31.
What conditions does trial NCT05365581 study?
This clinical trial studies the following conditions: Pancreatic Adenocarcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction (GEJ) Adenocarcinoma.
What interventions are being tested in trial NCT05365581?
The interventions under investigation include: Pembrolizumab (DRUG), Fluorouracil (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), ASP2138 (DRUG).
Who is sponsoring clinical trial NCT05365581?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05365581 being conducted?
This trial has 20 study locations across California, Illinois, Kansas, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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