Study on ASP546C for Adults with Gastroesophageal, Pancreatic, and Other Solid Tumors
Sponsor: Astellas Pharma Global Development, Inc.
ClinicalTrials ID:NCT07488676
This clinical trial is exploring the best dose of a new drug, ASP546C, for treating adults with certain types of cancer, including gastroesophageal, pancreatic, and other solid tumors. The study involves receiving the drug through an infusion every three weeks.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to find the most suitable dose of ASP546C for treating adults with gastric, gastroesophageal junction (GEJ), pancreatic, and other specific solid tumors. The GEJ is where the esophagus meets the stomach. The study has two parts. In Part 1, participants with gastric or GEJ cancer will receive either a higher or lower dose of ASP546C. In Part 2, participants with pancreatic or other solid tumors will receive the higher dose. Participants will visit the clinic for infusions and health checks, with the number of visits depending on their health and treatment status.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with gastroesophageal, pancreatic, or other specific solid tumors like colorectal or breast cancer.
- Cancer confirmed by scans within 28 days before starting the study.
- Have measurable or evaluable disease according to specific criteria.
- Tumor must express a protein called CLDN18.2.
- Have received at least one prior treatment for advanced cancer.
- Be in good overall health with a performance status of 0 or 1.
- Expected to live at least 12 more weeks.
- Women must not be pregnant and agree to use contraception during and after the study.
- Men must agree to use contraception and not donate sperm during and after the study.
- Willing to provide a tumor sample for research.
- Agree not to join another study while participating in this one.
Exclusion Criteria
- Have a type of cancer not included in the study or have had more than two prior treatments for advanced cancer.
- Have severe stomach issues like gastric outlet syndrome or significant bleeding.
- Have untreated brain cancer or mental health issues that are hard to control.
- Have unresolved lung inflammation or a history of certain lung diseases.
- Have active infections like HIV or hepatitis.
- Have other serious medical conditions or recent major surgeries.
- Have received certain treatments or vaccines recently that could interfere with the study.
- Have a known allergy to ASP546C or its components.
- Have a significant heart condition or other medical issues that could affect treatment safety.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| START Los Angeles | 90025 | Los Angeles | California |
| START Midwest | 49546 | Grand Rapids | Michigan |
| START New York | 10042 | Lake Success | New York |
| Duke Cancer Center Durham | 27710 | Durham | North Carolina |
| Next Oncology - Austin | 78758 | Austin | Texas |
| Next Oncology - Houston | 77054 | Houston | Texas |
| Next Oncology - Dallas | 75039 | Irving | Texas |
| START San Antonio | 78229 | San Antonio | Texas |
| START Mountain Region | 84119 | West Valley City | Utah |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.
