A First-in-Human, Phase III PET Imaging Study of 64Cu-GRIP B, a Radiotracer Targeting Granzyme B, in Patients With Advanced Malignancies

What this Trial Is About

Researchers are evaluating the use of a radiotracer called 64Cu-GRIP B with PET imaging to detect granzyme B, a biomarker produced by immune cells during immunotherapy, in patients with advanced cancers that have spread to nearby tissues or lymph nodes. This phase III study focuses on genitourinary cancers, including renal cell carcinoma, urothelial cancer, and metastatic castration-resistant prostate cancer, aiming to assess safety and usefulness of the imaging in monitoring immune response. Participants are divided into four groups based on cancer type metastatic genitourinary malignancies, renal cell and urothelial carcinoma, metastatic castration-resistant prostate cancer, and other solid tumors. All receive the 64Cu-GRIP B injection followed by PET scans at baseline. Some groups have additional scans at 8 weeks and at disease progression. Imaging methods include PETCT or PETMRI, with safety monitoring conducted at multiple time points after tracer injection. During the study, patients undergo scans, blood sampling, and tumor biopsies when applicable. Researchers monitor adverse events, tracer distribution, and tumor uptake patterns over time. Outcomes measured include safety, tracer pharmacokinetics, changes in tumor uptake values, and correlations with clinical outcomes such as response to immunotherapy and progression-free survival. Participants are followed for up to two years to assess long-term effects and disease progression.

64Cu-GRIP B in Patients With Advanced Malignancies