Early Access Program for Zolbetuximab
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06048081 |
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Expanded Access Status :
Available
First Posted : September 21, 2023
Last Update Posted : May 1, 2024
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| Tracking Information | |||||
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| First Submitted Date | September 15, 2023 | ||||
| First Posted Date | September 21, 2023 | ||||
| Last Update Posted Date | May 1, 2024 | ||||
| Descriptive Information | |||||
| Brief Title | Early Access Program for Zolbetuximab | ||||
| Brief Summary | This program is to provide zolbetuximab to people with stomach cancer or gastroesophageal junction (the junction between stomach and esophagus) cancer who have not yet been treated with chemotherapy, immunotherapy, or zolbetuximab and who have tested positive for claudin18.2 (a protein found in some cancer cells). People will work with their doctor to see if they are capable of being treated with zolbetuximab while they receive other standard medicines to treat their cancer. The program will allow people early access to zolbetuximab before the drug is fully approved. Zolbetuximab will be given through a vein. This is called an infusion. The infusion will happen during a person's treatment with other cancer medicines. Zolbetuximab will be given every 3 weeks. People will continue treatment until: they have medical problems (unwanted side effects) from the treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; or they do not come back for treatment. People will visit the clinic on certain days during their treatment. During these visits, the program doctors will check for any medical problems (unwanted side effects) from zolbetuximab, other cancer treatment, or both. At some visits, other checks will include a medical examination, laboratory tests and vital signs. Vital signs include temperature, pulse, and blood pressure. Also, blood and urine samples will be taken. People will visit the clinic within 7 days after stopping treatment. The program doctors will check for any medical problems (unwanted side effects) from zolbetuximab or their cancer treatment. Other checks will include a medical examination, laboratory tests, and vital signs. Then, people will have a follow-up visit about 30 days after stopping treatment. If people are having no health problems, the follow-up visit can happen over the telephone. |
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| Detailed Description | Not Provided | ||||
| Study Type | Expanded Access | ||||
| Expanded Access Type | Treatment IND/Protocol | ||||
| Intervention | Drug: zolbetuximab
intravenous infusion mFOLFOX6 or CAPOX (used at physician discretion) will be used in combination with zolbetuximab Other Name: IMAB362
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Expanded Access Status | Available | ||||
| Contacts |
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| Listed Location Countries | Germany, United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT06048081 | ||||
| Current Responsible Party | Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ) | ||||
| Original Responsible Party | Same as current | ||||
| Current Study Sponsor | Astellas Pharma Global Development, Inc. | ||||
| Original Study Sponsor | Same as current | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Astellas Pharma Inc | ||||
| Verification Date | April 2024 | ||||