NL-OMON51900招募中不适用
ImmunoPET imaging with 89Zr-DFO-REGN3767 in patients with advanced solid cancer prior to and during treatment with cemiplimab with or without platinum-based chemotherapy - LAG-3 PET imaging in advanced solid tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
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
- •investigator, based on available clinical data, may benefit from PD1 antibody
- •with or without platinum-based chemotherapy.
- •3. At least 1 lesion that is accessible per investigator*s assessment and
- •eligible for biopsy according to standard clinical care procedures.
- •4. 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.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •6. Life expectancy >= 12 weeks.
- •7. Adequate organ and bone marrow function as defined below:
- •a. Hemoglobin >=9.0 g/dL
- •b. Absolute neutrophil count >=1.5 x 109/L
- •c. Absolute lymphocyte count >=0.75 x 109/L
- •d. Platelet count >=100 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
- •f. Adequate hepatic function:
- •i. Total bilirubin <=1.5 x ULN (<=3 x ULN if liver tumor 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 tumor
- •involvement)
- •iii. Alanine aminotransferase (ALT) <=2.5 x ULN (<=5 x ULN if liver tumor
- •involvement)
- •iv. Alkaline phosphatase (ALP) <=2.5 x ULN (<=5 x ULN if liver or bone tumor
- •involvement)
- •8. Signed informed consent.
- •9. Willingness and ability to comply with all protocol required procedures.
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-DFO-REGN3767 injection.
- •2. Prior ICI treatment, including but not limited to anti-PD1 and anti-PD-L1
- •therapeutic antibodies in the past 12 months or >= 12 months ago, in case the
- •ICI treatment was terminated for progressive disease or toxicity.
- •3. Encephalitis, meningitis, or uncontrolled seizures in the year prior
- •4. Any unresolved toxicity (>CTCAE grade 2) from previous anti-cancer
- •therapy. Subjects with irreversible toxicity that is not reasonably expected
- •to be exacerbated by the investigational product may be included (e.g., hearing
- •loss, peripherally neuropathy)
- •5. 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.
- •6. Documented allergic or acute hypersensitivity reaction attributed to
- •antibody treatments
- •7. Major surgical procedure other than for diagnosis within 28 days prior to
- •89Zr-DFO-REGN3767 injection or anticipation of need for a major surgical
- •procedure during the course of the study.
- •8. For patients that will be treated with cemiplimab in combination with
- •platinum containing chemotherapy, the following additional criteria apply:
- •Leucopenia <3 x 109/L
- •Estimated glomerular filtration rate < 60 mL/min/1.73 m2
- •Cardiovascular disease, such as New York Heart Association cardiac disease
- •(Class II or greater), unstable angina, unstable cardiac arrhythmias,
- •myocardial infarction < 3 months ago, or cerebrovascular accident < 6 months
- •Hearing loss
- •Any other exclusion criteria, according to the local clinical practice
- •guidelines for the chosen chemotherapy regimen.
- •9. 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.
- •10. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g.,
- •bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
- •History of radiation pneumonitis in the radiation field (fibrosis) is
- •11. Treatment with systemic immunosuppressive medications (including but not
- •limited to prednisone, cyclophosphamide, azathioprine, methotrexate,
- •thalidomide, and anti-tumor necrosis factor agents) within 4 weeks prior to
- •89Zr-DFO-REGN3767 injection.
- •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 dis
研究者
相似试验
招募中
2 期
LAG3 PET; ImmunoPET imaging with 89Zr-DFO-REGN3767 in patients with advanced solid cancer prior to and during treatment with cemiplimab with or without platinum-based chemotherapy2024-516795-15-00Universitair Medisch Centrum Groningen38
已完成
不适用
ImmunoPET imaging with 89Zr-MPDL3280A in patients with locally advanced or metastatic solid tumors prior to and during MPDL3280A treatmentsolid tumors10027655cancerNL-OMON47805niversitair Medisch Centrum Groningen54
进行中（未招募）
1 期
LAG3 PET Imaging in Advanced Solid TumorsMetastatic Solid TumorNCT04706715University Medical Center Groningen41
招募中
不适用
A phase 1-2 immunoPET imaging study with ZED88082A in patients before and during treatment with 1) MPDL3280A or 2) PD-1 antibody plus or minus ipilimumabmetastases10027655CancerNL-OMON49728niversitair Medisch Centrum Groningen50
招募中
3 期
CD8 PET imaging study before and after CAR T-cell therapy2025-520560-18-00Universitair Medisch Centrum Groningen27