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

No results posted yet for this 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

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04169321 on ClinicalTrials.gov