Granzyme B PET Imaging Drug as a Predictor of Immunotherapy Response in Melanoma or NSCLC Participants
First in Human Safety of [68Ga]-NOTA-hGZP PET Imaging in Subjects with Melanoma or NSCLC
- Non-Small Cell Lung Cancer
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Subjects 18 years of age and older.
- Subjects with proven metastatic melanoma or NSCLC with at least two sites ≥ 20 mm in longest diameter as verified by CT.
- Subjects for whom pembrolizumab monotherapy treatment is planned.
- 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.
- 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.
- 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.
- Subjects who have received more than 2 cycles of pembrolizumab.
- 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.
- If female, nursing.
- Current treatment with systemic steroids, or immunosuppressive agents.
- 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.
- Phase 1
- Study Type
- 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
- None (Open Label)
|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.||
- Cytosite Biopharma Inc.
Study ContactCarey J Brett, M.Ed, LLB
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.