Solid Tumor, Unspecified, AdultPhase 1NCT04169321

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

A Phase 1 study testing Single Arm in people with Solid Tumor, Unspecified, Adult and Lymphoma, run by Cytosite Biopharma Inc. at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor, Unspecified, Adult, Lymphoma
What is being tested?: Single Arm
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 3 sitesin 2 countries
Study dates: 16 Jun 2020to 9 Jun 2025
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects 18 years of age and older.
Subjects with proven metastatic cancer that is going to be treated with one or more checkpoint inhibitors under the licensed indications for the cancer type. Checkpoint inhibitors include PD-1, PD-L1, CTLA-4 and LAG-3 inhibitors.
Subjects must have at least one lesion ≥ 15 mm in diameter or with two lesions both ≥ 15mm in diameter, when an optional biopsy is planned. Lesion measurements are taken from a diagnostic quality CT or MR image.
ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
Life expectancy of greater than 6 months.
Males and females willing to use adequate contraception prior to study and during study participation.

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If female, not of childbearing potential or negative pregnancy test prior to radiotracer injection.
Willing and able to understand and sign a written informed consent document.
Willing and able to undergo all study procedures.
Cohort 3 only: have archival lesion tissue available within 90 days of enrollment either from biopsy or surgery.

Who cannot join

Participants for whom adverse events due to agents administered more than 4 weeks earlier have not resolved to Grade 1 or less.
Has not received nor is expected to receive an investigational compound within 90 days prior to [68Ga]-NOTA-hGZP PET imaging. This includes checkpoint inhibitors that are not approved by the US FDA for the indications in this protocol.
Subjects who have received a prior checkpoint inhibitor.
Any acute or chronic inflammatory disease or medical conditions that in the investigator's opinion may interfere with the study procedures or the interpretation of the study results such as infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
Known brain metastases.
History of allergic reactions to compounds of similar chemical or biologic composition to [68Ga]-NOTA-hGZP or pembrolizumab.

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If female, nursing.
Current treatment with systemic steroids, or immunosuppressive agents. Participants with a condition requiring systemic treatment with either corticosteroids (< 10 mg daily prednisone equivalent) inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
Subjects who have exclusion criteria that would prevent them from receiving a CT scan.
Laboratory values
Leukocytes < 3000/mcL
Absolute neutrophil count < 1500 mcL
Platelets < 100,000 mCL
Total bilirubin > 1.5 x ULN
AST/ALT > 2.5 x ULN
Albumin < 2 g/dL
Alkaline phosphatase > 2.5 ULN
eGRF eGFR < 45 mL/min/1.73 m2
Patients who are stable but have values outside the specified ranges may be included with approval of the study medical monitor.

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

United States2 sites

University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

Taiwan1 site

Chang-Gung Memorial Hospital
Taoyuan City, Guishan, 333

Other trials in Taiwan

About this study

Official title: First in Human Safety of [68Ga]-NOTA-hGZP- PET Imaging in Subjects Receiving Checkpoint Inhibitor Immunotherapy

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

Read the 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
Being tested: Single Arm
Keywords: cancer immunotherapy, biomarkers, tumor, positron-emission tomography, Granzymes
Medical subject headings: Lymphoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Single ArmDrug
Also called [68Ga]-NOTA-hGZP, CSB-111
[68Ga]-NOTA-hGZP is a PET imaging agent.

Study groups in NCT04169321
Study group	Role	What they receive
Single Arm	Experimental	All participants will receive a mass dose of 40 μg or less of [68Ga]-NOTA-hGZP (radioactivity dose of 3 mCi to 8 mCi) and have a PET and CT scan. Receives: Drug: Single Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with clinically meaningful changes in physical examination findings, vital signs or blood chemistry
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. Platelets (/mcL)
4. Total bilirubin (mg/d)
5. AST/ALT (unitless)
6. Albumin (g/dL)
7. Alkaline phosphatase (IU/L)
8. eGRF (mL/min/1.73 m2)
Measured: up to 4 to 6 hours post-injection
Number of participants with changes in ECG
Clinically significant changes from baseline to follow-up analysis in ECG change in QT (ms) Quantification of [68Ga]-NOTA-hGZP PET accumulation at tumor site in subjects after treatment with checkpoint inhibitor therapy as determined by region of interest analysis (SUVmean).
Measured: up to 4 to 6 hours post-injection
Number of participants with treatment-related Adverse Events (AEs)
The absolute number of participants with AEs according to CTCAE 5.0
Measured: Between time of injection and 3 days post injection

Secondary outcomes (4)

Evaluation of the accumulation of [68Ga]-NOTA-hGZP in tumor foci in participants receiving checkpoint inhibitor therapy (absolute number of avid lesions per subject)
Identification by the central reader of the number of avid lesions observed in each subject and the number of subjects with avid lesions seen on the PET images
Measured: up to one-hour post injection
Quantification of accumulation of [68Ga]-NOTA-hGZP in tumor foci in participants receiving checkpoint inhibitor therapy.
To be determined by region of interest analysis the mean standardized uptake value (SUVmean) (SUV does not have any units)
Measured: up to one-hour post injection
Evaluate the correlation of [68Ga]-NOTA-hGZP accumulation in tumor foci to 6-month outcome.
Compare quantified [68Ga]-NOTA-hGZP uptake to participant treatment response in individual lesions as assessed at 6-month clinical follow-up and/or CT assessments.
The number of lesions that were avid and the lesions that showed a decrease in size compared to those which increased in size.
Measured: 6 months
Correlate uptake of [68Ga]-NOTA-hGZP tracer and granzyme B expression as assessed on optional excisional biopsy when available (melanoma only).
Compare granzyme B protein quantification from biopsied tissue to the [68Ga]-NOTA-hGZP PET uptake acquired at the same location.
Measured: up to one-hour post injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jun 20209 Jun 2025

First posted19 Nov 2019
Study start16 Jun 2020
Primary completion30 Mar 2025
Study completion9 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid Tumor, Unspecified, AdultStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Model description: Multiple center, open label, non-randomized, single dose study, in subjects with cancer undergoing or treatment with a checkpoint inhibitor either as a monotherapy or in combination. subjects. Eligible subjects will receive an injection of \[68Ga\]-NOTA-hGZP pre checkpoint inhibitor administration and a second dose between 5 and 42 days post initial checkpoint inhibitor administration. Upon dosing each subject will undergo PET scans at 40, 60 and 90 minutes post dosing. The images will be analyzed for the distribution of radioactivity. Subjects will be followed for adverse events for approximately 4-6 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)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04169321
Sponsor's protocol ID: 2019-hGZP-101.12
Status last verified: Oct 2026
First submitted: 4 Nov 2019
Last updated: 13 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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