Granzyme B PET Imaging Drug as a Predictor of Immunotherapy Response in Melanoma or NSCLC Participants
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Melanoma
- Non -Small Cell Lung Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Multiple center, open label, non-randomized, single dose study, in metastatic melanoma or NSCLC subjects. Eligible subjects will receive an injection of [68Ga]-NOTA-hGZP followed by dynamic PET imaging. The images will be analyzed for the distribution of radioactivity. Subjects will be followed for adverse events for approximately 5-6 hours post injection or until pembrolizumab injection plus a follow up phone call to assess adverse events 1-3 days after injection.Masking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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, single dose drug trial in metastatic melanoma or NSCLC participants.
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, single dose drug trial in metastatic melanoma or NSCLC participants.
Tracking Information
- NCT #
- NCT04169321
- Collaborators
- Massachusetts General Hospital
- University of Alabama at Birmingham
- Chang Gung Memorial Hospital
- Investigators
- Study Director: Colin G Miller, PhD CytoSite Bio Inc.
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