NCT04169321

Granzyme B PET Imaging Drug as a Predictor of Immunotherapy Response to Checkpoint Inhibitors

Completed Phase 1 Last updated 22 August 2025

What this trial tests

Phase 1 trial testing Single Arm in Solid Tumor, Unspecified, Adult in 13 participants. Completed in 9 June 2025.

Timeline

16 June 2020

Primary endpoint
30 March 2025

9 June 2025

Quick facts

Lead sponsor	Cytosite Biopharma Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	13
Start date	16 June 2020
Primary completion	30 March 2025
Estimated completion	9 June 2025
Sites	3 locations across Taiwan, United States

Drugs / interventions tested

• Single Arm

Conditions studied

• Solid Tumor, Unspecified, Adult — all drugs for Solid Tumor, Unspecified, Adult →
• Lymphoma — all drugs for Lymphoma →

Sponsor

Cytosite Biopharma Inc. — full company profile →

Who can join

18 and older, any sex, with Solid Tumor, Unspecified, Adult or Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of melanoma, version 3.0.
   Pavlick AC, Ariyan CE, Buchbinder EI, Davar D, et al · · 2023 · cited 38× · PMID 37852736 · DOI 10.1136/jitc-2023-006947
2. Molecular imaging to support cancer immunotherapy.
   van de Donk PP, Oosting SF, Knapen DG, van der Wekken AJ, et al · · 2022 · cited 30× · PMID 35922089 · DOI 10.1136/jitc-2022-004949
3. Preclinical PET Imaging of Granzyme B Shows Promotion of Immunological Response Following Combination Paclitaxel and Immune Checkpoint Inhibition in Triple Negative Breast Cancer.
   Napier TS, Hunter CL, Song PN, Larimer BM, et al · · 2022 · cited 22× · PMID 35214172 · DOI 10.3390/pharmaceutics14020440
4. Harnessing imaging tools to guide immunotherapy trials: summary from the National Cancer Institute Cancer Imaging Steering Committee workshop.
   Shankar LK, Schöder H, Sharon E, Wolchok J, et al · · 2023 · cited 21× · PMID 36858729 · DOI 10.1016/s1470-2045(22)00742-2
5. Imaging cellular immunotherapies and immune cell biomarkers: from preclinical studies to patients.
   Volpe A, Adusumilli PS, Schöder H, Ponomarev V. · · 2022 · cited 19× · PMID 36137649 · DOI 10.1136/jitc-2022-004902
6. Molecular Immune Targeted Imaging of Tumor Microenvironment.
   Rakhshandehroo T, Smith BR, Glockner HJ, Rashidian M, et al · · 2022 · cited 19× · PMID 35223381 · DOI 10.7150/ntno.66556
7. Imaging of Activated T Cells.
   Sako MO, Larimer BM. · · 2023 · cited 12× · PMID 36460341 · DOI 10.2967/jnumed.122.264097
8. Probing immune infiltration dynamics in cancer by in vivo imaging.
   Ng TSC, Allen HH, Rashidian M, Miller MA. · · 2022 · cited 10× · PMID 35219177 · DOI 10.1016/j.cbpa.2022.102117