NL-OMON56589尚未招募2 期
A phase II, open label, multi-center study of 89Zr-DF-Crefmirlimab for CD8 positron emission tomography in patients with locally advanced or metastatic solid tumours - CD8 PET imaging in metastatic solid tumours
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age >= 18 years at the time of signing informed consent. 2. Patients with histologically confirmed diagnosis of locally advanced or metastatic solid cancer types who, according to the opinion of the principal investigator, based on available clinical data, may benefit from anti-PD1 antibody therapy. 3. Disease progression following first-line therapy or any subsequent treatment line or no superior standard line of therapy available. 4. At least 1 lesion that is accessible per investigator*s assessment and eligible for biopsy according to standard clinical care procedures. 5. Measurable disease, as defined by standard RECIST v1.1. Previously irradiated lesions should not be counted as target lesions except for lesions that have progressed after radiotherapy administered at least 3 months earlier. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Life expectancy >= 12 weeks. 8. Adequate organ and bone marrow function as defined below: a. Hemoglobin >=9.0 g/dL b. Absolute neutrophil count >=1.0 x 109/L c. Absolute lymphocyte count >=0.75 x 109/L d. Platelet count >=75 x 109/L e. Serum creatinine <=1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate > 30 mL/min/1.73 m2. A 24-hour urine creatinine collection may substitute for the calculated creatinine clearance to meet eligibility criteria. f. Adequate hepatic function: i. Total bilirubin <=1.5 x ULN (<=3 x ULN if liver tumour involvement); Patients with Gilbert*s syndrome do not need to meet total bilirubin requirements, provided their total bilirubin is unchanged from their baseline. Gilbert*s syndrome must be documented appropriately as past medical history. ii. Aspartate aminotransferase (AST) <=2.5 x ULN (<=5 x ULN if liver tumour involvement) iii. Alanine aminotransferase (ALT) <=2.5 x ULN (<=5 x ULN if liver tumour involvement) iv. Alkaline phosphatase (ALP) <=2.5 x ULN (<=5 x ULN if liver or bone tumour involvement) 9. Signed informed consent. 10. Willingness and ability to comply with all protocol required procedures. 11. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate (< 1% per year) when used consistently and correctly)).
排除标准
- •1. Treatment with any approved anti-cancer therapy, investigational agent or
- •participation in another clinical trial with therapeutic intent within 28 days
- •prior to 89Zr-Df-crefmirlimab infusion and nivolumab or cetrelimab treatment.
- •2. Symptomatic, untreated brain metastasis, leptomeningeal disease, or spinal
- •cord compression. Patients are eligible if central nervous system (CNS)
- •metastases are adequately treated and neurologically stable for at least 2
- •weeks prior to enrollment.
- •3. Prior ICI treatment, including but not limited to anti-PD1, anti-PD-L1 and
- •anti-CTLA4 therapeutic antibodies.
- •4. Major surgical procedure other than for diagnosis within 28 days prior to
- •89Zr-Df-crefmirlimab infusion or anticipation of need for a major surgical
- •procedure during the course of the study.
- •5. History of autoimmune disease, including but not limited to myasthenia
- •gravis, myositis, autoimmune hepatitis, systemic lupus erythematous, rheumatoid
- •arthritis, inflammatory bowel disease, vascular thrombosis associated with
- •antiphospholipid syndrome, Wegener*s granulomatosis, Sjögren*s syndrome,
- •Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis.
- •Patients with a history of autoimmune-related hypothyroidism on a stable dose
- •of thyroid replacement hormone may be eligible for his study.
- •Patients with controlled type I diabetes mellitus on a stable dose of insulin
- •regimen may be eligible for this study.
- •6. Treatment with systemic immunosuppressive medications (including but not
- •limited to prednisone, cyclophosphamide, azathioprine, methotrexate,
- •thalidomide, and anti-tumour necrosis factor agents) within 4 weeks prior to
- •89Zr-Df-crefmirlimab infusion.
- •Patients who have received acute, low-dose, systemic immunosuppressant
- •medications (e.g. a one-time of dexamethasone for nausea) may be enrolled in
- •the study after discussion with and approval by the sponsor.
- •The use of inhaled corticosteroids for chronic obstructive pulmonary disease,
- •mineralocorticoids (e.g. fludrocortisone) for patients with orthostatic
- •hypotension, and low-dose supplemental corticosteroids for adrenocortical
- •insufficiency are allowed.
- •7. Prior allogeneic bone marrow transplantation or solid organ transplant.
- •8. Active infection with human immunodeficiency virus (HIV), hepatitis B,
- •hepatitis C or tuberculosis infection; or diagnosis of immunodeficiency.
- •Patients will be tested for hepatitis C virus (HCV) and hepatitis B virus
- •(HBV) at screening.
- •Patients with known HIV infection who have controlled infection (undetectable
- •viral load (HIV ribonucleic acid (RNA) polymerase chain reaction (PCR)) and CD4
- •count above 350 either spontaneously or on a stable antiviral regimen are
- •permitted. For patients with controlled HIV infection, monitoring will be
- •performed per local standards.
- •Patients with hepatitis B who have a controlled infection (serum HBV
- •deoxyribonucleic acid (DNA) PCR that is below the limit of detection AND
- •receiving anti-viral therapy for hepatitis B) are permitted. Patients with
- •controlled infections must undergo periodic monitoring of HBV DNA. Patients
- •must remain on anti-viral therapy for at least 6 months beyond the last dose of
- •investigational study drug.
- •Patients who are HCV antibody positive who have controlled infection
- •(undetectable HCV RNA by PCR
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