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NCT04169321 · ClinicalTrials.gov registry record · Phase 1
Granzyme B PET Imaging Drug as a Predictor of Immunotherapy Response to Checkpoint Inhibitors
A Phase 1 study of Lymphoma and Solid Tumor, Unspecified, Adult, sponsored by Cytosite Biopharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 3
- Study locations
NCT04169321: Completed Phase 1 study of Lymphoma and Solid Tumor, Unspecified, Adult, sponsored by Cytosite Biopharma.
NCT04169321 is a Phase 1 study of Lymphoma and Solid Tumor, Unspecified, Adult that has completed, run by Cytosite Biopharma. The registered enrollment target is 13 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04169321, a Phase 1 study of Lymphoma and Solid Tumor, Unspecified, Adult, has completed, sponsored by Cytosite Biopharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 3
- Study locations
Study 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
Primary Outcome
Clinically significant changes from baseline in physical examination findings Clinically significant changes from baseline to follow-up analysis in systolic and diastolic blood pressure (mmHg) Clinically significant changes from baseline to follow-up analysis in heart rate (beats per minute) Clinically significant changes in respiration rate. Clinically significant changes from baseline to follow-up analysis in blood chemistry for: 1. Leukocytes (/mcL), 2. Absolute neutrophil count (mcL) 3.
Conditions Studied
Interventions
- DRUG Single Arm
Study Locations (3)
Alabama
- University of Alabama at Birmingham - Birmingham
Massachusetts
- Massachusetts General Hospital - Boston
Guishan
- Chang-Gung Memorial Hospital - Taoyuan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2020-06-16 |
| Est. Completion | 2025-06-09 |
| Phase | Phase 1 |
What the finished NCT04169321 record still lists
NCT04169321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Single Arm is the first listed.
NCT04169321 reports a single indexed study location in Alabama, Massachusetts, Guishan.
Frequently Asked Questions
What is clinical trial NCT04169321 about?
NCT04169321 is a clinical study titled "Granzyme B PET Imaging Drug as a Predictor of Immunotherapy Response to Checkpoint Inhibitors". 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
What is the current status of trial NCT04169321?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2020-06-16. Estimated completion is 2025-06-09.
What conditions does trial NCT04169321 study?
This clinical trial studies the following conditions: Lymphoma, Solid Tumor, Unspecified, Adult.
What interventions are being tested in trial NCT04169321?
The interventions under investigation include: Single Arm (DRUG).
Who is sponsoring clinical trial NCT04169321?
This trial is sponsored by Cytosite Biopharma, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04169321 being conducted?
This trial has 3 study locations across Alabama, Massachusetts, Guishan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04169321's enrollment target sits among peer trials
13 268th of 299 higher than 32 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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