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.
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
- Are there results?
- None posted in the registry
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.
Show all 10Show fewer
- 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.
Show all 19Show fewer
- 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.
3 sites in 2 countries
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
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 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:
- Leukocytes (/mcL),
- Absolute neutrophil count (mcL)
- Platelets (/mcL)
- Total bilirubin (mg/d)
- AST/ALT (unitless)
- Albumin (g/dL)
- Alkaline phosphatase (IU/L)
- 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Cytosite Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, University of Alabama at Birmingham, Chang Gung Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Colin G Miller, PhD, Study director, CytoSite Bio Inc.
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Human Safety of [68Ga]-NOTA-hGZP- PET Imaging in Subjects Receiving Checkpoint Inhibitor Immunotherapy
- ClinicalTrials.gov ID
- NCT04169321
- Acronym / sponsor ID
- 2019-hGZP-101.12
- Conditions
- Solid Tumor, Unspecified, Adult, Lymphoma
- Keywords
- cancer immunotherapy, biomarkers, tumor, positron-emission tomography, Granzymes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Cytosite Biopharma Inc.Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, University of Alabama at Birmingham, Chang Gung Memorial Hospital
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 9 Jun 2025 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Single ArmAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single ArmAlso: [68Ga]-NOTA-hGZP, CSB-111[68Ga]-NOTA-hGZP is a PET imaging agent. | Drug | Single Arm |
Primary outcome
Number of participants with clinically meaningful changes in physical examination findings, vital signs or blood chemistry
Time frame: up to 4 to 6 hours post-injection
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)
Number of participants with changes in ECG
Time frame: up to 4 to 6 hours post-injection
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).
Number of participants with treatment-related Adverse Events (AEs)
Time frame: Between time of injection and 3 days post injection
The absolute number of participants with AEs according to CTCAE 5.0
4 secondary outcomes
Evaluation of the accumulation of [68Ga]-NOTA-hGZP in tumor foci in participants receiving checkpoint inhibitor therapy (absolute number of avid lesions per subject)
Time frame: up to one-hour post injection
Quantification of accumulation of [68Ga]-NOTA-hGZP in tumor foci in participants receiving checkpoint inhibitor therapy.
Time frame: up to one-hour post injection
Evaluate the correlation of [68Ga]-NOTA-hGZP accumulation in tumor foci to 6-month outcome.
Time frame: 6 months
Correlate uptake of [68Ga]-NOTA-hGZP tracer and granzyme B expression as assessed on optional excisional biopsy when available (melanoma only).
Time frame: up to one-hour post injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor, Unspecified, Adult
Active, not recruitingPhase 1
RNR Inhibitor COH29 in Treating Patients With Solid Tumors That Are Refractory to Standard Therapy or For Which No Standard Therapy Exists
Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruiting
Assessment Tool for Older Patients With Cancer
Cognitive/Functional Effects, Psychosocial Effects of Cancer and Its Treatment
Active, not recruiting
Psychotherapy Intervention for Latinos With Advanced Cancer
Solid Tumor, Solid Tumor, Adult
Active, not recruiting
Psychotherapy Intervention for Latinos With Adv Cancer
Solid Tumor, Solid Tumor, Adult
Active, not recruiting
Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
Breast Cancer, Colon Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin G Miller, PhD study director
CytoSite Bio Inc.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with clinically meaningful changes in physical examination findings, vital signs or blood chemistry (time frame: up to 4 to 6 hours post-injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.