Granzyme B PET Imaging Drug as a Predictor of Immunotherapy Response to Checkpoint Inhibitors
NCT04169321 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2025-08-22
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
Conditions
- Solid Tumor, Unspecified, Adult
- Lymphoma
Interventions
- DRUG
-
Single Arm
\[68Ga\]-NOTA-hGZP is a PET imaging agent.
Sponsors & Collaborators
-
Massachusetts General Hospital
collaborator OTHER -
University of Alabama at Birmingham
collaborator OTHER -
Chang Gung Memorial Hospital
collaborator OTHER -
Cytosite Biopharma Inc.
lead INDUSTRY
Principal Investigators
-
Colin G Miller, PhD · CytoSite Bio Inc.
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-16
- Primary Completion
- 2025-03-30
- Completion
- 2025-06-09
- FDA Drug
- Yes
Countries
- United States
- Taiwan
Study Locations
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