Purpose

First in Human Safety of [68Ga]-NOTA-hGZP PET Imaging in Subjects with Melanoma or NSCLC

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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
  11. Leukocytes < 3000/mcL
  12. Absolute neutrophil count < 1500 mcL
  13. Platelets < 100,000 mCL
  14. Total bilirubin > 1.5 x ULN
  15. AST/ALT > 2.5 x ULN
  16. Albumin < 2 g/dL
  17. Alkaline phosphatase > 2.5 ULN
  18. 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
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.
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • [68Ga]-NOTA-hGZP

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Jonathan McConathy, MD PhD

More Details

Status
Recruiting
Sponsor
Cytosite Biopharma Inc.

Study Contact

Carey J Brett, M.Ed, LLB
978-230-7850
cbrett@cytositebio.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.