[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cytosite Biopharma Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100597350","phase-1-csb-321-ph-1-in-immunotherapy-for-the-treatment-of-cancer-100597350",false,"NCT07057349","CSB-321 Ph 1 in Immunotherapy for the Treatment of Cancer","Phase 1 Multi-cohort Evaluation of [18F]CSB-321 PET Imaging in Participants Receiving Immunotherapy for the Treatment of Cancer","Inclusion Criteria:\n\n1. Participants 18 years of age and older.\n2. Participants with either proven metastatic cancer that are going to be treated with one or more checkpoint inhibitors or immunotherapy under the licensed indications for the cancer type. Checkpoint inhibitors include PD-1, PD-L1, CTLA-4 and LAG-3 inhibitors OR Participants with unresectable or metastatic uveal melanoma planned to be treated with tebentafusp-tebn\n3. 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).\n4. ECOG performance status ≤ 2 (Karnofsky ≤ 60%).\n5. Life expectancy of greater than 6 months.\n6. If female, not of childbearing potential or must have a negative pregnancy test prior to each radiotracer injection.\n7. Willing and able to undergo all study procedures.\n8. Need archival lesion tissue ideally available within 90 days of enrollment either from biopsy or surgery without intervening therapy.\n\nExclusion Criteria:\n\n1. 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.\n2. 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.\n3. 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).\n4. 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.\n5. 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.\n6. History of allergic reactions to compounds of similar chemical or biologic composition to \\[18F\\]CSB-321.\n7. Current treatment with systemic steroids, or immunosuppressive agents. Participants with a condition requiring systemic treatment with either corticosteroids (\\\u003C 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.\n8. Participants who are unwilling or unable to have a CT scan.\n9. Males and females unwilling to use adequate contraception prior to study and during study participation.\n10. If female, nursing.\n11. Unwilling and\u002For unable to sign a written informed consent document.\n12. Laboratory values\n\n    1. Leukocytes \\\u003C 2000\u002FmcL (CTCAE grade 3)\n    2. Absolute neutrophil count \\\u003C 1000 mcL (CTCAE grade 3)\n    3. Platelets \\\u003C 75,000 mcL (CTCAE grade 2)\n    4. Total bilirubin \\> 1.5 x ULN, unless participant has Gilbert' disease.\n    5. AST\u002FALT \\> 5 x ULN (CTCAE grade 3)\n    6. Albumin \\\u003C 2 g\u002FdL\n    7. Alkaline phosphatase \\> 5 ULN (CTCAE grade 3)\n    8. eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2 Participants who are stable but have values outside the specified ranges may be included with approval of the study medical monitor.\n13. Participants with a QTcF of greater than 470 ms as measured by 12-lead ECG.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","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.",[26,27],"Metastatic Cancer","Unresectable Solid Tumor",[29,30,31,32],"cancer immunotherapy","biomarkers, tumor","positron-emission tomography","Granzymes","NOT_YET_RECRUITING","2025-06-30",{"date":36,"type":37},"2025-07-09","ACTUAL",{"date":39,"type":20},"2025-09-01",{"date":41,"type":20},"2029-02",{"name":43,"class":44},"Cytosite Biopharma Inc.","INDUSTRY",""]