EUCTR2015-005806-12-ES进行中（未招募）1 期
A phase I/II, open-label, multi-center study of the safety and efficacy of BLZ945 as single agent and in combination with PDR001 in adults patients with advanced solid tumors
ovartis Farmaceútica S.A.0 个研究点目标入组 151 人开始时间: 2016年8月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 151
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
- •1. Phase I: Patients with advanced/metastatic solid tumors, with measurable or unmeasurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
- •2. Phase I: Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution’s guidelines. Patient must be willing to undergo a new tumor biopsy at screening, and during treatment.
- •3. Phase II: Patients with advanced/metastatic tumors in the below selected indications, with at least one measurable lesion as determined by RECIST v1.1 or Response Assessment in Neuro-Oncology Criteria RANO (glioblastoma) advanced pancreatic cancer who failed to respond to standard treatment or progressed on or after treatment with gemcitabine advanced triple negative breast cancer, who failed to respond to standard treatment or progressed on or after standard treatment recurrent glioblastoma who failed to respond or progressed on radiotherapy and temozolomide except for patients with O6- methylguanine-DNA methyltransferase (MGMT) unmethylated newly diagnosed gliobastoma who may have received radiation therapy only.
- •Other protocol-defined inclusion criteria may apply
- •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 101
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •1. History of severe hypersensitivity reactions to monoclonal antibodies.
- •2. Impaired cardiac function or clinically significant cardiac disease, including any of the following: Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA grade = 2), uncontrolled hypertension or clinically significant arrhythmia QTcF >470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome Acute myocardial infarction or unstable angina pectoris < 3 months prior to study entry
- •3. Active autoimmune disease or a documented history of autoimmune disease, including ulcerative colitis and Crohn’s disease or any condition that requires systemic steroids, except vitiligo or resolved asthma/atopy that is treated with broncho-dilators (e.g. albuterol). Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.
- •4. Systemic steroid therapy or any immunosuppressive therapy (=10mg/day prednisone or equivalent). Topical, inhaled, nasal and ophthalmic steroids are not prohibited.
- •5. Use of any vaccines against infectious diseases (e.g. varicella, pneumococcus) within 4 weeks of initiation of study treatment.
- •6. Patient who received the following therapies: Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity, e.g. mitomycin C and nitrosoureas, 4 weeks is indicated as washout period. Pre-treatment with anti-CTLA-4 antibodies in combination with any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathway. Patients pre-treated with anti-CTLA-4 as single agent must have minimum 8 weeks washout period between the last dose of anti-CTLA-4 and the first dose of PDR001.
- •Participation in an interventional, investigational non-immunotherapy study within 2 weeks of the first dose of study treatment Major surgery within 2 weeks of the first dose of study treatment (mediastinoscopy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery).
- •Use of hematopoietic colony-stimulating growth factors (e.g. G-CSF, GM-CSF, M-CSF) and thrombopoietin mimetics =2 weeks prior to start of study drug. An erythroid stimulating agent is allowed as long as it was initiated at least 2 weeks prior to the first dose of study treatment and the patient is on a stable dose.
- •Radiotherapy within 2 weeks of the first dose of study drug, except for palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass. To allow evaluation for response to treatment, patients enrolled in the phase II part must have remaining measurable disease that has not been irradiated.
- •7. Patient receiving treatment with medications that either strong inducers or inhibitors of CYP2C8 or CYP3A4/5, or patients receiving medication that prohibits proton pump inhibitors and that cannot be discontinued at least 1 week prior to start of treatment and for the duration of the study
- •8. Known human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. Patients whose HBV or HCV infection is controlled by antiviral therapy should not be excluded.
- •Other protocol-defined exclusion criteria may apply.
研究者
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