COMPLETED

Granzyme B PET Imaging Drug as a Predictor of Immunotherapy Response to Checkpoint Inhibitors

Conditions

Solid Tumor, Unspecified, Adult Lymphoma cancer immunotherapy biomarkers, tumor positron-emission tomography Granzymes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

First in Human Safety of \[68Ga\]-NOTA-hGZP PET Imaging in subjects with cancer undergoing treatment with a checkpoint inhibitor either as a monotherapy of in combination I-O therapy

Official Title

First in Human Safety of [68Ga]-NOTA-hGZP- PET Imaging in Subjects Receiving Checkpoint Inhibitor Immunotherapy

Quick Facts

Study Start:2020-06-16

Study Completion:2025-06-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04169321

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subjects 18 years of age and older. 2. Subjects with proven metastatic cancer that is going to be treated with one or more checkpoint inhibitors under the licensed indications for the cancer type. Checkpoint inhibitors include PD-1, PD-L1, CTLA-4 and LAG-3 inhibitors. 3. Subjects must have at least one lesion ≥ 15 mm in diameter or with two lesions both ≥ 15mm in diameter, when an optional biopsy is planned. Lesion measurements are taken from a diagnostic quality CT or MR image. 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. 10. Cohort 3 only: have archival lesion tissue available within 90 days of enrollment either from biopsy or surgery.	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. This includes checkpoint inhibitors that are not approved by the US FDA for the indications in this protocol. 3. Subjects who have received a prior checkpoint inhibitor. 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. Participants with a condition requiring systemic treatment with either corticosteroids (\< 10 mg daily prednisone equivalent) inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. 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

Inclusion Criteria

Exclusion Criteria

1. Subjects 18 years of age and older.
2. Subjects with proven metastatic cancer that is going to be treated with one or more checkpoint inhibitors under the licensed indications for the cancer type. Checkpoint inhibitors include PD-1, PD-L1, CTLA-4 and LAG-3 inhibitors.
3. Subjects must have at least one lesion ≥ 15 mm in diameter or with two lesions both ≥ 15mm in diameter, when an optional biopsy is planned. Lesion measurements are taken from a diagnostic quality CT or MR image.
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.
10. Cohort 3 only: have archival lesion tissue available within 90 days of enrollment either from biopsy or surgery.

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. This includes checkpoint inhibitors that are not approved by the US FDA for the indications in this protocol.
3. Subjects who have received a prior checkpoint inhibitor.
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. Participants with a condition requiring systemic treatment with either corticosteroids (\< 10 mg daily prednisone equivalent) inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
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

Contacts and Locations

Principal Investigator

Colin G Miller, PhD

STUDY_DIRECTOR

CytoSite Bio Inc.

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Cytosite Biopharma Inc.

Colin G Miller, PhD, STUDY_DIRECTOR, CytoSite Bio Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-06-16

Study Completion Date2025-06-09

Study Record Updates

Study Start Date2020-06-16

Study Completion Date2025-06-09

Terms related to this study

Keywords Provided by Researchers

cancer immunotherapy
biomarkers, tumor
positron-emission tomography
Granzymes

Additional Relevant MeSH Terms

Solid Tumor, Unspecified, Adult
Lymphoma