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, subjects will undergo biopsy of tumor. The aseptic collection of tumor material will occur in a manner suitable for DNA and RNA extraction and sequencing. Sequencing for this study will be performed in a laboratory that performs whole exome and RNA sequencing. Quality thresholds will include metrics such as base calling quality, coverage, allelic read percentages, strand bias, and alignment quality. Upon successful antibody production, the antibodies will be delivered to each subject through a series of infusions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Chimeric antibodies
Penn State Cancer Institute
Hershey, Pennsylvania, United States
Safety: Frequency of Grade III or greater adverse events
Frequency of Grade III or greater adverse events
Time frame: From first dose of treatment through endpoint evaluation at 6 months
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