Granzyme B PET Imaging Drug as a Predictor of Immunotherapy Response in Melanoma or NSCLC Participants
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|ClinicalTrials.gov Identifier: NCT04169321|
Recruitment Status : Not yet recruiting
First Posted : November 19, 2019
Last Update Posted : November 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Non-Small Cell Lung Cancer||Drug: Single Arm||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Multiple center, open label, non-randomized, single dose study, in metastatic melanoma or NSCLC subjects. Eligible subjects will receive an injection of [68Ga]-NOTA-hGZP followed by dynamic PET imaging. The images will be analyzed for the distribution of radioactivity. Subjects will be followed for adverse events for approximately 5-6 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)|
|Official Title:||First in Human Safety of [68Ga]-NOTA-hGZP PET Imaging in Subjects With Melanoma or Non-Small Cell Lung Cancer (NSCLC)Treated With Pembrolizumab|
|Estimated Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||October 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Single Arm
All participants will receive a mass dose of 30 μg or less of [68Ga]-NOTA-hGZP (radioactivity dose of 3 mCi to 15 mCi) and have a PET scan.
Drug: Single Arm
[68Ga]-NOTA-hGZP is a PET imaging agent.
Other Name: [68Ga]-NOTA-hGZP
- Number of participants with clinically meaningful changes in physical examination findings, vital signs or blood chemistry [ Time Frame: up to 5 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:
- 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)
- Number of participants with changes in ECG [ Time Frame: up to 5 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 pembrolizumab 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
- Evaluation of the accumulation of [68Ga]-NOTA-hGZP in tumor foci in pembrolizumab participants (absolute number of avid lesions per subject) [ Time Frame: up to one-hour post injection ]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
- Quantification of accumulation of [68Ga]-NOTA-hGZP in tumor foci in pembrolizumab participants [ Time Frame: up to one-hour post injection ]To be determined by region of interest analysis the mean standardized uptake value (SUVmean) (SUV does not have any units)
- Evaluate the correlation of [68Ga]-NOTA-hGZP accumulation in tumor foci to 6-month outcome. [ Time Frame: 6 months ]
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.
- 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 ]Compare granzyme B protein quantification from biopsied tissue to the [68Ga]-NOTA-hGZP PET uptake acquired at the same location.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04169321
|Contact: Carey J Brett, M.Ed, LLBfirstname.lastname@example.org|
|Study Director:||Colin G Miller, PhD||Cytosite Biopharma Inc.|