Study on Zolbetuximab for Adults with Stomach and Gastroesophageal Cancer
Sponsor: Astellas Pharma Global Development, Inc.
ClinicalTrials ID:NCT03505320
This clinical trial is exploring the use of Zolbetuximab, a new treatment for adults with advanced stomach or gastroesophageal cancer. The study aims to see how well Zolbetuximab works alone and in combination with other treatments.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
Zolbetuximab is being tested as a treatment for cancer in the stomach area or where the esophagus meets the stomach. Many people with this cancer have a protein called Claudin 18.2 in their tumors. Zolbetuximab attaches to this protein, helping the immune system attack the cancer. This study is for adults with advanced cancer in these areas, especially if the cancer cannot be removed by surgery or has spread to other parts of the body. Participants will receive Zolbetuximab alone or with other treatments like chemotherapy or immunotherapy. The study will monitor how well the treatment controls the cancer and any side effects.
Description
This study is testing Zolbetuximab, a drug that targets a protein called CLDN18.2 found in some stomach and gastroesophageal cancers. The study includes several parts: pre-screening, screening, treatment, and follow-up. Participants will receive Zolbetuximab alone or with other treatments like chemotherapy or immunotherapy. The study will check how well the treatment works and its safety. Participants will have regular health checks, blood tests, and scans to monitor their cancer. They will also provide tumor samples at certain times. After treatment, participants will have follow-up visits and may receive phone check-ups every three months.
Eligibility Criteria
Inclusion Criteria
- Women must not be pregnant and agree to use birth control during the study and for a period after.
- Men must agree to use contraception and not donate sperm during the study and for a period after.
- Participants must have confirmed stomach or gastroesophageal cancer with the CLDN18.2 marker.
- Cancer must be advanced, unresectable, or metastatic.
- Participants must not join another study while on treatment.
- Must have a good performance status and life expectancy of at least 12 weeks.
- Must meet specific blood and organ function criteria.
- Specific criteria apply to different study groups, such as having measurable disease or not having received certain prior treatments.
Exclusion Criteria
- Severe allergic reactions to Zolbetuximab or similar drugs.
- Recent use of other investigational treatments or immunosuppressive therapy.
- Significant stomach issues like blockages or bleeding.
- History of brain metastases or certain infections.
- Recent heart issues or active infections.
- Active autoimmune diseases requiring treatment.
- Major surgery or radiotherapy close to the study start.
- Other cancers requiring treatment.
- Specific criteria apply to different study groups, such as known drug allergies or certain medical conditions.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.