Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Granzyme B PET Imaging Drug as a Predictor of Immunotherapy Response in Melanoma or NSCLC Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04169321
Recruitment Status : Not yet recruiting
First Posted : November 19, 2019
Last Update Posted : November 19, 2019
Sponsor:
Collaborators:
Massachusetts General Hospital
University of Alabama at Birmingham
Information provided by (Responsible Party):
Cytosite Biopharma Inc.

Tracking Information
First Submitted Date  ICMJE November 4, 2019
First Posted Date  ICMJE November 19, 2019
Last Update Posted Date November 19, 2019
Estimated Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date October 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2019)
  • 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:
    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 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Granzyme B PET Imaging Drug as a Predictor of Immunotherapy Response in Melanoma or NSCLC Participants
Official Title  ICMJE First in Human Safety of [68Ga]-NOTA-hGZP PET Imaging in Subjects With Melanoma or Non-Small Cell Lung Cancer (NSCLC)Treated With Pembrolizumab
Brief Summary First in Human Safety of [68Ga]-NOTA-hGZP PET Imaging in Subjects with Melanoma or NSCLC
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, single dose drug trial in metastatic melanoma or NSCLC participants.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Melanoma
  • Non-Small Cell Lung Cancer
Intervention  ICMJE Drug: Single Arm
[68Ga]-NOTA-hGZP is a PET imaging agent.
Other Name: [68Ga]-NOTA-hGZP
Study Arms  ICMJE 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.
Intervention: Drug: Single Arm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 18, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date October 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects 18 years of age and older.
  2. Subjects with proven metastatic melanoma or NSCLC with at least two sites ≥ 20 mm in longest diameter as verified by CT.
  3. Subjects for whom pembrolizumab monotherapy treatment is planned.
  4. ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
  5. Life expectancy of greater than 6 months.
  6. Males and females willing to use adequate contraception prior to study and during study participation.
  7. If female, not of childbearing potential or negative pregnancy test prior to radiotracer injection.
  8. Willing and able to understand and sign a written informed consent document.
  9. Willing and able to undergo all study procedures.

Exclusion Criteria:

  1. Participants for whom adverse events due to agents administered more than 4 weeks earlier have not resolved to Grade 1 or less.
  2. Has not received nor is expected to receive an investigational compound within 90 days prior to [68Ga]-NOTA-hGZP PET imaging.
  3. Subjects who have received more than 2 cycles of pembrolizumab.
  4. 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.
  5. Known brain metastases.
  6. History of allergic reactions to compounds of similar chemical or biologic composition to [68Ga]-NOTA-hGZP or pembrolizumab.
  7. If female, nursing.
  8. Current treatment with systemic steroids, or immunosuppressive agents.
  9. Subjects who have exclusion criteria that would prevent them from receiving a CT scan.
  10. Laboratory values

    1. Leukocytes < 3000/mcL
    2. Absolute neutrophil count < 1500 mcL
    3. Platelets < 100,000 mCL
    4. Total bilirubin > 1.5 x ULN
    5. AST/ALT > 2.5 x ULN
    6. Albumin < 2 g/dL
    7. Alkaline phosphatase > 2.5 ULN
    8. 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Carey J Brett, M.Ed, LLB 978-230-7850 cbrett@cytositebio.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04169321
Other Study ID Numbers  ICMJE 2019-hGZP-101.05
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cytosite Biopharma Inc.
Study Sponsor  ICMJE Cytosite Biopharma Inc.
Collaborators  ICMJE
  • Massachusetts General Hospital
  • University of Alabama at Birmingham
Investigators  ICMJE
Study Director: Colin G Miller, PhD Cytosite Biopharma Inc.
PRS Account Cytosite Biopharma Inc.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP