The primary objective is to evaluate methods for AGS-003 production from surgical (stage I) and metastatic biopsy (stage II) Renal Cell Carcinoma (RCC) and a small subset of other GU cancers (expansion cohort) specimens using core needle biopsy in subjects with RCC or other GU cancers. Specifically, this study will evaluate the feasibility of RNA amplification from total tumor RNA isolated from tissues obtained by core needle tumor biopsy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
14
Duke University Medical Center
Durham, North Carolina, United States
Success rate for tumor RNA isolation and amplification
To Determine the success rate for tumor RNA isolation and amplification create a minimum of 10 doses of AGS-003, as defined by a minimum concentration of ≥84 µg/µL in typically greater than 150 µL final volume RNA. (Tissue obtained at time of surgery or biopsy depending on stage)
Time frame: At time of surgery or during biopsy
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