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

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cytosite Biopharma Inc.
• Collaborators: Chang Gung Memorial Hospital; Massachusetts General Hospital; University of Alabama at Birmingham

Criteria

Inclusion Criteria:

1. Subjects 18 years of age and older.

2. Subjects with proven metastatic melanoma or NSCLC with one lesion at least ≥ 15 mm in diameter or with two lesions both ≥ 15mm in diameter, where an optional biopsy is planned. Lesion measurements are taken from a diagnostic quality CT or MR image.

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.