NL-OMON54263招募中不适用
AN OPEN-LABEL, MULTICENTER, PHASE I STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY CLINICAL ACTIVITY OF RO7428731 IN PARTICIPANTS WITH GLIOBLASTOMA EXPRESSING MUTANT EPIDERMAL GROWTH FACTOR RECEPTOR VARIANT III - EGFRvIII - BP42573
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
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
- •- Aged >=18 years
- •- Life expectancy of >= 12 weeks, in the opinion of the Investigator
- •- Diagnosis of GBM based on on world health organization (WHO) classification
- •of central nervous system (CNS) tumors, 5th edition
- •- Confirmed Epidermal growth factor receptor variant III (EGFRvIII)
- •- expression by a College of American Pathologists (CAP)/Clinical Laboratory
- •Improvement Amendments (CLIA) certified central laboratory, in an archival
- •tumor tissue sample using an investigational EGFRvIII immunohistochemistry
- •(IHC) assay
- •- Karnofsky Performance Status (KPS) Score of >=70%
- •- Adequate organ functions within 7 days prior to start of study treatment
- •- Coagulation activity: International Normalized Ratio <=1.5
- •- Willingness to abide by contraceptive measures for the duration of the study
- •Additional Inclusion Criteria for Part I and Part II only
- •- Participants whose tumors have an unmethylated (Part I and Part II) or
- •methylated (Part I only) O6-methylguanine-DNA methyltransferase
- •(MGMT) promotor status based on local assessment - Participants (in
- •-- Adult participants with newly diagnosed EGFRvIII-positive GBM with
- •unmethylated MGMT promotor status who have completed standard of care (SoC)
- •therapy with surgical resection and adjuvant radiotherapy with or without
- •concomitant TMZ. Participants are allowed to have received any number of cycles
- •maintenance
- •-- Adult participants with newly diagnosed EGFRvIII-positive GBM with
- •methylated MGMT promotor status who have completed SoC with surgical resection
- •and adjuvant radiotherapy with concomitant and maintenance TMZ or discontinued
- •TMZ maintenance due to reasons other than progressive disease
- •- Participants (in Part II):
- •--- Adult participants with newly diagnosed EGFRvIII-positive GBM with
- •unmethylated MGMT promotor status who have completed SoC
- •therapy with surgical resection and adjuvant RT with or without concomitant
- •temozolomide (TMZ)
- •- Treatment start date at least 4 weeks after but not more than 9 weeks from
- •the last dose of RT or TMZ, whichever was administered last (applicable to all
- •participants in part I/II)
- •- Baseline MRI within 2 weeks prior to start of study treatment with no
- •evidence of progressive disease per response assessment in neurooncology (RANO)
- •criteria from the post-operative MRI to the baseline MRI
- •Additional Inclusion Criteria for Part III and Part IVA only
- •- Previous first line treatment with at least radiotherapy (RT) and, for
- •participants with a methylated MGMT promotor status, TMZ
- •- Documented first or second recurrence of GBM
- •- At least one measurable GBM lesion as per RANO criteria prior to initiation
- •of study treatment that meets the following criteria: I) Contrast enhancing and
- •clearly defined, bi-dimensionally measurable margins AND ii) At least two
- •perpendicular diameters measuring >=10 mm X >=10 mm
排除标准
- •- Participants with infratentorial tumors and tumors primarily located in or
- •close to critical structures
- •- Presence of extracranial metastatic or leptomeningeal disease
- •- Known hypersensitivity to immunoglobulins or to any other component of the
- •investigational medicinal product (IMP) formulation
- •- Therapy with any other investigational drug within 28 days or 5 half-lives of
- •the drug before the first day of study treatment
- •- Treatment with systemic immunosuppressive medication within 2 weeks prior to
- •initiation of study treatment
- •- Administration of a live, attenuated vaccine within 28 days before first day
- •of study treatment or anticipation that such a live attenuated vaccine will be
- •required during the study
- •- Acute treatment-related toxicities from prior anti-cancer therapy that have
- •not resolved to Grade <=1 or returned to baseline, except for alopecia (any
- •grade), Grade 2 peripheral neuropathy, and any laboratory changes that still
- •meet the inclusion criteria defined above
- •- Significant cardiovascular disease
- •- Active bleeding or pathological condition that carries a high risk of
- •bleeding, including inherited and acquired coagulopathies
- •- History or evidence upon physical/neurological examination of central nervous
- •system disease unrelated to cancer and potentially interfering with protocol
- •treatment unless adequately controlled by medication
- •- Dementia or altered mental status that would prohibit informed consent
- •- Alcohol or drug dependency or abuse
- •- Participants unable to undergo an MRI with contrast
- •- Any other disease, metabolic dysfunction, physical examination finding, or
- •clinical laboratory finding that contraindicates the use of an investigational
- •drug, may affect the interpretation of the results, or may render the
- •participant at high risk from treatment complications
- •Exclusion Criteria-applicable for Part I and Part II only
- •- Recurrent malignant gliomas
- •Exclusion criteria-applicable for Part III and Part IVA only
- •- More than two recurrence of GBM
- •- Prior EGFRvIII targeting agents, anti-angiogenic therapy and/ or gene-therapy
- •for the treatment of GBM and gliomas
- •Specific Exclusion Criteria if Pretreatment with Obinutuzumab is Implemented
- •- History of progressive multifocal leukoencephalopathy
- •- Active tuberculosis requiring treatment within 3 years prior to initiation of
- •study treatment or latent tuberculosis that has not been appropriately treated
- •- Positive test results for human T-cell lymphotropic virus 1 (HTLV-1). This
- •testing is required in participants from endemic countries (Japan,
- •countries in the Caribbean basin, South America, Central America, sub- Saharan
- •Africa, and Melanesia)
- •- Known hypersensitivity to any of the components of obinutuzumab
研究者
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