Using a new imaging drug to predict cancer treatment response

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

This study is testing a new imaging drug to see if it can help predict how well immunotherapy works for people with metastatic cancer.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cytosite Biopharma Inc. (industry)
• Drugs / interventions: pembrolizumab, prednisone
• Locations: 3 sites (Birmingham, Alabama and 2 other locations)
• Trial ID: NCT04169321 on ClinicalTrials.gov

What this trial studies

This Phase I clinical trial evaluates the safety and effectiveness of a novel radioactive PET imaging drug, [68Ga]-NOTA-hGZP, in patients with metastatic cancer undergoing treatment with checkpoint inhibitors. The study is multi-center and open-label, focusing on assessing the drug's ability to predict clinical responses to immunotherapy within two treatment cycles. Participants will receive the imaging agent to determine its potential as a biomarker for treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with proven metastatic cancer who are scheduled to receive checkpoint inhibitor therapy.

Not a fit: Patients who do not have metastatic cancer or are not eligible for checkpoint inhibitor treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the ability to predict which patients will respond to immunotherapy, potentially leading to more personalized treatment plans.

How similar studies have performed: While this approach is novel, similar studies exploring imaging biomarkers in cancer immunotherapy have shown promise, indicating potential for success.

Eligibility criteria

Inclusion 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.

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. 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

Patients who are stable but have values outside the specified ranges may be included with approval of the study medical monitor.

Where this trial is running

Birmingham, Alabama and 2 other locations

• University of Alabama at Birmingham — Birmingham, Alabama, United States (COMPLETED)
• Massachusetts General Hospital — Boston, Massachusetts, United States (COMPLETED)
• Chang-Gung Memorial Hospital — Taoyuan City, Guishan, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Colin G Miller, PhD

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