NCT04169321

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 Receiving Checkpoint Inhibitor Immunotherapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Cytosite Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor, Unspecified, Adult
• Lymphoma

Interventions

Type	Name	Description
DRUG	Single Arm	\[68Ga\]-NOTA-hGZP is a PET imaging agent.

Timeline

• Start date: 2020-06-16
• Primary completion: 2025-03-30
• Completion: 2025-06-09
• First posted: 2019-11-19
• Last updated: 2025-08-22

Locations

3 sites across 2 countries: United States, Taiwan

Regulatory

• FDA-regulated drug study