CTIS2024-510964-21-00招募中1 期
Single-arm dose-escalation Phase 1/2 study of olaptesed pegol (NOX-A12) in combination with irradiation in inoperable or partially resected first-line glioblastoma patients with unmethylated MGMT promoter with a 3-arm expansion group including fully resected patients and combination with bevacizumab or pembrolizumab - SNOXA12C401
TME Pharma AG0 个研究点目标入组 36 人开始时间: 2024年3月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
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 65+（—）
- 性别
- All
入选标准
- •Dose Escalation Cohorts:, 4.Patient agrees to subcutaneous port implantation, 5.Newly diagnosed, histologically confirmed, supratentorial WHO grade IV glioblastoma, 6.Status post biopsy or incomplete resection (detectable residual tumor as per postoperative T1-weighted, contrast-enhanced MRI scan), 7.Unmethylated MGMT promoter status, 8.Maximum Eastern Cooperative Oncology Group (ECOG) score 2, Expansion Group Arms A-C:, 1.Written informed consent, 2.Age = 18 years, 3.Patient agreement to diagnostic and scientific work-up of glioblastoma tissue obtained during the preceding surgery or biopsy (e.g., MGMT promoter analysis, cytogenetic markers such as IDH-1 mutations, etc.), 4.Patient agrees to subcutaneous port implantation, 9.Estimated minimum life expectancy 3 months, 5.Newly diagnosed, histologically confirmed, supratentorial WHO grade IV glioblastoma, 6.a) Status post biopsy or incomplete (detectable residual tumor as per postoperative T1-weighted, contrast-enhanced MRI scan) or complete resection (Arm A) OR b) Status post complete resection (Arm B) OR c) Status post complete or incomplete resection (circumscribed enhancing tumor = 5.0 cm in largest diameter as per postoperative T1-weighted, contrast-enhanced MRI scan) (Arm C), 7.Unmethylated MGMT promoter status, 8.Maximum Eastern Cooperative Oncology Group (ECOG) score 2, 9.Estimated minimum life expectancy 3 months, 10.Stable or decreasing dose of corticosteroids during the week prior to inclusion, 11.The following laboratory parameters should be within the ranges specified: •Total bilirubin = 1.5 x upper limit normal (ULN) •Creatinine = 1.5 x ULN or glomerular filtration rate = 60 mL/min/1.73m² •ALT (alanine transaminase) = 3 x ULN •AST (aspartate transaminase) = 3 x ULN, 12.Female patients of child-bearing potential must have a negative serum pregnancy test within 21 days prior to enrollment and agree to use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly such as contraceptive implants, vaginal rings, sterilization, or sexual abstinence) during and for 3 months (6 months Arm A, 4 months Arm C) following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations), 13.Male patients must use an effective barrier method of contraception during study and for 3 months (6 months Arm A, 4 months Arm C) following the last dose if sexually active with a FCBP, 10.Stable or decreasing dose of corticosteroids during the week prior to inclusion, 11.The following laboratory parameters should be within the ranges specified: •Total bilirubin = 1.5 x upper limit normal (ULN) •Creatinine = 1.5 x ULN or glomerular filtration rate = 60 mL/min/1.73m² •ALT (alanine transaminase) = 3 x ULN •AST (aspartate transaminase) = 3 x ULN, 12. Female patients of child-bearing potential must have a negative serum pregnancy test within 21 days prior to enrollment and agree to use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly such as contraceptive implants, vaginal rings, sterilization, or sexual abstinence) during and for 3 months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations), 13.Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP, 1.Written
排除标准
- •Dose Escalation Cohorts:, 9.Placement of Gliadel® wafer, seeds, or ferromagnetic nanoparticles, 10.Pregnancy or lactation, 11.Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, chronic liver disease (e.g., cirrhosis, hepatitis), diabetes mellitus, or subjects with either of the following: fasting blood glucose (FBG defined as fasting for at least 8 hours) = 200 mg/dL (7.0 mmol/L), or HbA1c = 8%, chronic renal disease, pancreatitis, chronic pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements. Patients must be free of any clinically relevant disease (other than glioma) that would, in the treating investigator's opinion, interfere with the conduct of the study or study evaluations, 12.Treatment not initiated within 6 weeks after first biopsy or surgery of glioblastoma, 13.Prior enrolment into this study, Expansion Group Arms A and B:, 1.Inability to understand and collaborate throughout the study or inability or unwillingness to comply with study requirements, 2.Participation in any clinical research study with administration of an investigational drug or therapy within 30 days from screening visit or observation period of competing studies, 3.Contra-indication or known hypersensitivity to MRI contrast agents, bevacizumab (Arm A only), olaptesed pegol or polyethylene glycol, 4.Planned hypofractionated radiotherapy, 1.Inability to understand and collaborate throughout the study or inability or unwillingness to comply with study requirements, 5.Cytostatic therapy (chemotherapy) within the past 5 years, 6.History of other cancers (except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient was disease-free for = 5 years), 7.Secondary malignancy which is currently active, 8.Clinically significant or uncontrolled cardiovascular disease, including •Myocardial infarction in the previous 12 months •Uncontrolled angina •Congestive heart failure (New York Heart Association functional classification of =2) •Diagnosed or suspected congenital long QT syndrome •QTc prolongation on an electrocardiogram prior to entry (>470 ms) •Uncontrolled hypertension (blood pressure = 160/95 mmHg) •Heart rate <50/min on the baseline electrocardiogram •History of ventricular arrhythmias of any clinically significant type (such as ventricular tachycardia, ventricular fibrillation or torsades de pointes) •Cerebrovascular accident, 9.Prior radiotherapy to the head, 10.Any other previous or concomitant experimental glioblastoma treatments, 11.Placement of Gliadel® wafer, seeds, or ferromagnetic nanoparticles, 12.Patients with a history of arterial or venous thrombosis (or any other disease) requiring permanent intake of anticoagulants (Arm A only), 13.Pregnancy or lactation, 14.Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, chronic liver disease (e.g., cirrhosis, hepatitis), diabetes mellitus, or subjects with either of the following: fasting blood glucose (FBG defined as fasting for at least 8 hours) = 200 mg/dL (7.0 mmol/L), or HbA1c = 8%, chronic renal disease, pancreatitis, chronic pulmonary disease, auto-immune diseases or psychiatric illness/social situations that would limit compliance with study requirements. Patients must be free of any clinically relevant disease (other than glioma) that would, in the treating investigat
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