Lung Cancer Clinical Trial

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

Summary

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

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Full 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, two dose study to evaluate the safety of [68Ga]-NOTA-hGZP and the ability to predict the clinical response to checkpoint inhibitor therapy within 2 cycles of treatment.

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Eligibility Criteria

Inclusion Criteria:

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.
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.
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.
Cohort 3 only: have archival lesion tissue available within 90 days of enrollment either from biopsy or surgery.

Exclusion Criteria:

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. This includes checkpoint inhibitors that are not approved by the US FDA for the indications in this protocol.
Subjects who have received a prior checkpoint inhibitor.
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. 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.
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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT04169321

Recruitment Status:

Recruiting

Sponsor:

Cytosite Biopharma Inc.

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There are 3 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States More Info
Jonathan McConathy, MD PhD
Contact
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Pedram Heidari, MD
Contact
617-459-7277
Ryan Sullivan, MD
Principal Investigator
Chang-Gung Memorial Hospital
Taoyuan City Guishan, 333, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT04169321

Recruitment Status:

Recruiting

Sponsor:


Cytosite Biopharma Inc.

How clear is this clinincal trial information?

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