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Spots Global Cancer Trial Database for Granzyme B PET Imaging Drug as a Predictor of Immunotherapy Response to Checkpoint Inhibitors

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We do not endorse or review these studies in any way.

Trial Identification

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

Interventions

Single Arm

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Alabama at Birmingham, Birmingham, Alabama, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

Chang-Gung Memorial Hospital, Taoyuan City, Guishan, Taiwan

Contact Details

Name: Colin G Miller, PhD

Affiliation: CytoSite Bio Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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