Condition: Advanced Solid Tumors · Sponsor: Astellas Pharma Global Development, Inc.
ASP1002 is being studied in people with tumors that have spread to nearby tissue (locally advanced) that cannot be removed by surgery (unresectable) or tumors that have spread to other parts of the body (metastatic). Claudin 4 protein, or CLDN4, is a protein found on tumors in different parts of the body. ASP1002 is thought to work by attaching to the CLDN4 protein in the tumor. This switches on the body's immune system to attack the tumor. Before ASP1002 can be used, researchers need to collect information about the safety of ASP1002 and how people with tumors tolerate it. In this study, ASP1002 will be given to humans for the first time. It will either be given by itself or together with other cancer treatments. These include standard chemotherapies (mFOLFOX6, FOLFIRI, TAS-102, pemetrexed, carboplatin, and docetaxel) and immunotherapies (bevacizumab, pembrolizumab, and ramucirumab). Immunotherapy is a treatment that works with the body's immune system to treat tumors. This is an early development study. These studies are mostly about safety, but also to find the most suitable dose. Other aims are to learn if ASP1002 shows signs of slowing down tumor growth, to learn how the body processes ASP1002, and to check if there are changes in the CLDN4 protein or the immune system after treatment. The main aims of the study are to check the safety of ASP1002 by itself and given with standard chemotherapies and immunotherapies in people with solid tumors and how well they tolerate…
This description comes directly from the study's public registry record.
Astellas Pharma Global Development, Inc. · 800-888-7704 · Astellas.registration@astellas.com
Always discuss trial participation with your own doctor first.
| Yale University Cancer Center | New Haven, Connecticut, United States | Recruiting |
| Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut | Plainville, Connecticut, United States | Recruiting |
| University of Florida | Gainesville, Florida, United States | Recruiting |
| University of Iowa Hospitals | Iowa City, Iowa, United States | Recruiting |
| Norton Cancer Institute | Louisville, Kentucky, United States | Recruiting |
| Henry Ford Hospital | Detroit, Michigan, United States | Recruiting |
| HealthPartners Cancer Research Center | Saint Paul, Minnesota, United States | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York, New York, United States | Recruiting |
| University Hospitals of Cleveland | Cleveland, Ohio, United States | Recruiting |
| Prisma Health-Upstate Cancer Institute | Greenville, South Carolina, United States | Completed |
| SCRI Oncology Partners | Nashville, Tennessee, United States | Completed |
| University of Texas Southwestern | Dallas, Texas, United States | Completed |
+ 3 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05719558