Moonshot Antibodies
The purpose of this research is to study the safety and effectiveness of investigational antibodies attacking certain areas on the surface of cancer cells so that the body can kill the cancer cells. The antibodies will be made in a laboratory from cells taken from each subject's tumor so they will be made specifically per subject. The first step is to take blood and tumor samples so that the laboratory can produce antibodies specific to each subject's tumor. During this process, the study team will identify specific areas on the cancer cells that are not normally present in healthy cells so that the antibodies can find the cancer cells that should be destroyed. The second step is to deliver the antibodies to each subject through a series of infusions.
This is a Phase I open-label, multicenter study to evaluate the safety and feasibility of treating with chimeric antibodies that target mutated cell surface proteins. Up to 12 evaluable subjects will be treated at up to 5 study sites. Evaluable subjects are those who receive at least 4 doses of treatment. A maximum of 16 subjects will be enrolled, regardless of the number of treatment doses administered. After consent is obtained to acquire tumor and normal cells, it will be determined if sufficient archived tumor tissue is available. In the absence of sufficient archived tumor tissue, subje…
Inclusion Criteria: 1. Subjects 18 years of age or older who have biopsy proven cancer. The following types of malignancy will be eligible: Stage IV cancer of the following types: breast cancer, colon cancer, esophageal cancer, kidney cancer, lung cancer, lymphoma, melanoma, ovarian cancer, pancreatic cancer, bladder, urothelial carcinoma, head and neck cancers, prostate cancer, sarcomas, and stomach cancer. 2. Subjects who have refractory or progressive disease after at least 1 line of systemic treatment or who have declined additional curative standard of care therapy(ies). 3. Subjects…
Chimeric antibodies
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