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Brief Title: Granzyme B PET Imaging Drug as a Predictor of Immunotherapy Response to Checkpoint Inhibitors
Official Title: First in Human Safety of [68Ga]-NOTA-hGZP- PET Imaging in Subjects Receiving Checkpoint Inhibitor Immunotherapy
Study ID: NCT04169321
Brief Summary: First in Human Safety of \[68Ga\]-NOTA-hGZP PET Imaging in subjects with cancer undergoing treatment with a checkpoint inhibitor either as a monotherapy of in combination I-O therapy
Detailed Description: This is a first in human research study (Phase I clinical trial) to test the safety and effectiveness of a new radioactive PET imaging drug and biomarker \[68Ga\]-NOTA-hGZP. It is a multi-center, open label, non-randomized, two dose study to evaluate the safety of \[68Ga\]-NOTA-hGZP and the ability to predict the clinical response to checkpoint inhibitor therapy within 2 cycles of treatment.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Chang-Gung Memorial Hospital, Taoyuan City, Guishan, Taiwan
Name: Colin G Miller, PhD
Affiliation: CytoSite Bio Inc.
Role: STUDY_DIRECTOR