This phase I/II clinical trial evaluates if using a radiotracer targeting granzyme B, 64-copper granzyme targeting restricted interaction peptide specific to family member B (64 Cu-GRIP B) with positron emission tomography (PET) imaging can be safe and useful for detecting granzyme B (GrB) in patients with advanced cancers that has spread to nearby tissue or lymph nodes (advanced). Granzyme B (GrB) is a biomarker produced by immune cells in response to immunotherapy, which may highlight tumors that are more likely to respond to treatment. The study population is focused on genitourinary (GU) malignancies, including renal cell and urothelial cancer, two tumor types with high mutational burden and tumor infiltrating lymphocytes compared to other tumor types, and have a predictable response rate at the population level to immune checkpoint inhibitors. The information gained from this trial may allow researchers to develop future trials where 64Cu-GRIP B PET may serve as a biomarker to monitor early response to immunomodulatory therapies which are used to stimulate or suppress the immune system and may help the body fight cancer.
Histologically-confirmed metastatic solid tumor malignancy (3 Male, 3 Female)
Locally advanced or metastatic disease on conventional imaging
Histologically-confirmed metastatic renal cell carcinoma (any histologic sub-type) or urothelial carcinoma
Locally advanced or metastatic disease on conventional imaging
Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
Is currently pregnant or breastfeeding.
Rahul Aggarwal
Lead sponsor
University of California, San Francisco
Sponsor institution
National Cancer Institute (NCI)
Collaborator
U.S. Army Medical Research Acquisition Activity
Collaborator