Clinical Trial · NCT07057349

Phase 1 Multi-cohort Evaluation of [18F]CSB-321 PET Imaging in Participants Receiving Immunotherapy for the Treatment of Cancer

Overview

Single-center with the option to expand to multi-center, international, open label, non-randomized, multiple-dose, multi-cohort study, in participants with metastatic or unresectable cancer. Eligible participants will receive an initial injection of [18F]CSB-321 followed by PET imaging prior to administration of the I-O therapy and a second and third injection post treatment each with PET imaging. The images will be analyzed for the distribution of radioactivity. Participants will be followed for adverse events up to 3-4 hours post injection. Available clinical, imaging, and histology data will be collected at follow-up to establish the disease progression for evaluation of [18F]CSB-321.

Sponsor

Cytosite Biopharma Inc

Phase

Phase 1

ClinicalTrials.gov

NCT07057349

Study contact

Kimmai T Phan, M.S.

kphan@cytositebio.com 215 6481208 ext 710

Chanelle Hunter, PhD

chunter@cytositebio.com 2156481208 ext 707

Drug / Compound

[18F]CSB-321

Isotope(s):

Target(s):

Granzyme B

Eligibility

Inclusion

Need archival lesion tissue ideally available within 90 days of enrollment either from biopsy or surgery without intervening therapy.
Willing and able to undergo all study procedures.
Participants must have at least one lesion ≥ 15 mm in diameter or with two lesions both ≥ 15mm in diameter, when an optional biopsy is planned from one of the lesions. Lesion measurements are taken from a diagnostic quality computerized tomography (CT) or Magnetic Resonance Imaging (MRI).
Life expectancy of greater than 6 months.
ECOG performance status ≤ 2 (Karnofsky ≤ 60%).
If female, not of childbearing potential or must have a negative pregnancy test prior to each radiotracer injection.

Exclusion

History of allergic reactions to compounds of similar chemical or biologic composition to \[18F\]CSB-321.
Participants with a QTcF of greater than 470 ms as measured by 12-lead ECG.
Participants for whom adverse events due to agents administered more than 4 weeks earlier have not resolved to Grade 1 or less, except for immune checkpoint inhibitor related endocrinopathies except for immune checkpoint inhibitor related endocrinopathies or deemed unlikely to be clinically significant by the investigator.
Platelets \< 75,000 mcL (CTCAE grade 2)
Albumin \< 2 g/dL
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.
Absolute neutrophil count \< 1000 mcL (CTCAE grade 3)
Participants who have received a prior checkpoint inhibitor in the last year except for participants in cohort 3 (Prior checkpoint inhibitors are allowed for this cohort).
If female, nursing.
Total bilirubin \> 1.5 x ULN, unless participant has Gilbert' disease.
Participants in cohort 2 (ipilimumab with nivolumab) who have received or are expected to receive an investigational compound within 90 days prior to \[18F\]CSB-321 PET imaging. This includes immunotherapies that are not approved by the US FDA for the indications in this protocol.
AST/ALT \> 5 x ULN (CTCAE grade 3)
Laboratory values
Alkaline phosphatase \> 5 ULN (CTCAE grade 3)
Participants who have received chemotherapy in the prior 6 months or are anticipated to receive chemotherapy in the 6 months following the initial \[18F\]CSB-321 injection for cohorts 2 and 3.
Leukocytes \< 2000/mcL (CTCAE grade 3)
Participants who are unwilling or unable to have a CT scan.
eGFR \< 45 mL/min/1.73 m2 Participants who are stable but have values outside the specified ranges may be included with approval of the study medical monitor.
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.
Males and females unwilling to use adequate contraception prior to study and during study participation.