EUCTR2017-003182-94-DE进行中（未招募）1 期
AN OPEN-LABEL, MULTICENTER, PHASE II STUDY TO EVALUATE THE THERAPEUTIC ACTIVITY OF RO6874281, AN IMMUNOCYTOKINE, CONSISTING OF INTERLEUKIN-2 VARIANT (IL-2V) TARGETING FIBROBLAST ACTIVATION PROTEIN-? (FAP), IN COMBINATION WITH ATEZOLIZUMAB (ANTI-PD-L1), ADMINISTERED INTRAVENOUSLY, IN PARTICIPANTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age >= 18 years
- •- Measurable disease, as defined by Response Evaluation Criteria in Solid
- •Tumors Version 1.1 (RECIST v1.1)
- •- Eastern Cooperative Oncology Group Performance Status 0 or 1 or
- •Karnofsky Performance Score >= 70
- •- Life expectancy of >= 12 weeks
- •- Absence of rapid disease progression or threat to vital organs or critical
- •anatomical sites (e.g., central nervous system [CNS] metastasis,
- •respiratory failure due to tumor compression, spinal cord compression)
- •requiring urgent alternative medical intervention.
- •- Confirmed at least one tumor lesion with location accessible to safely
- •biopsy per clinical judgment of the treating physician and the
- •participant's consented willingness to undergo baseline and on
- •treatment tumor biopsies for PD biomarker analysis (not applicable to
- •Part I Cohort A).
- •- Consent to provide an archival tumor tissue sample
- •- Willingness to undergo baseline and on-treatment tumor biopsies for
- •pharmacodynamic biomarker analysis
- •- Adequate cardiovascular, hematological, liver and renal function
- •- Adverse events related to any previous radiotherapy, chemotherapy, or
- •surgical procedure must have resolved to Grade <= 1, except alopecia
- •and Grade 2 peripheral neuropathy
- •- Participants with unilateral pleural effusion (indications other than
- •NSCLC) are eligible if they fulfill both of the following:
- •a) New York Heart Association Class 1
- •b) Forced expiratory volume 1 and forced vital capacity >70% predicted
- •value; participants with lung metastases should present with Diffusing
- •capacity of the lungs for carbon monoxide >60 % of predicted value
- •- For male and female participants: The contraception and abstinence
- •requirements are intended to prevent exposure of an embryo to the
- •study treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •- Symptomatic or untreated central nervous system (CNS) metastases
- •- History of treated asymptomatic CNS metastases
- •- Spinal cord compression not definitively treated with surgery and/or
- •radiation or previously diagnosed and treated spinal cord compression
- •without evidence that disease has been clinically stable for >= 2 weeks
- •before enrollment
- •- Leptomeningeal disease
- •- An active second malignancy
- •- Evidence of significant, uncontrolled concomitant diseases that could
- •affect compliance with the protocol or interpretation of results, including
- •diabetes mellitus, history of relevant pulmonary disorders, and known
- •autoimmune diseases or other disease with ongoing fibrosis
- •- Episode of significant cardiovascular/cerebrovascular acute disease
- •within 6 months before study treatment administration, including any of
- •the following: hypertensive crisis/encephalopathy, uncontrolled
- •hypertension, unstable angina, transient ischemic attack/stroke,
- •congestive heart failure of any New York Heart Association classification,
- •serious cardiac arrhythmia requiring treatment, history of
- •thromboembolic events, hypertensive encephalopathy
- •- Active or uncontrolled infections
- •- Known Human immunodeficiency virus or active hepatitis A (HAV)
- •hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D (HDV) or
- •hepatitis E (HEV) infection
- •- Severe infection within 4 weeks before study treatment administration
- •including, but not limited to, hospitalization for complications of
- •infection, bacteremia, or severe pneumonia
- •- History of chronic liver disease or evidence of hepatic cirrhosis
- •- Dementia or altered mental status that would prohibit informed
- •- History of, active or suspicion of autoimmune disease, including but not
- •limited to systemic lupus erythematosus, rheumatoid arthritis,
- •inflammatory bowel disease, vascular thrombosis associated with
- •antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's
- •syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis,
- •vasculitis, or glomerulonephritis
- •* Participants with a history of autoimmune hypothyroidism on a
- •stable dosage of thyroid replacement hormone may be eligible with
- •approval by the Medical Monitor
- •* Participants with controlled type 1 diabetes mellitus on a stable
- •insulin regimen may be eligible for this study with approval by the
- •Medical Monitor
- •- History of idiopathic pulmonary fibrosis, pneumonitis, organizing
- •pneumonia, or evidence of active pneumonitis on screening chest
- •computed tomography scan. History of radiation pneumonitis in the
- •radiation field is permitted
- •- Bilateral pleural effusion confirmed by x-ray
- •- Any other diseases, metabolic dysfunction, physical examination
- •finding, or clinical laboratory finding that give reasonable suspicion of a
- •disease or condition that would contraindicate the use of an
- •investigational drug
- •- Concurrent therapy with any other investigational drug
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研究者
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