NL-OMON48548已完成不适用
Phase 1/1b Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 as Monotherapy and in Combination with AMG 404 in Subjects with Glioblastoma or Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII) - 20160132
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 26
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 64（—）
入选标准
- •* Written informed consent, subject is at least 18 years of age
- •* Eastern Cooperative Oncology Group (ECOG, Appendix F) Performance Status of *
- •* Life expectancy of at least 3 months, in the opinion of the investigator.
- •* Must have pathologically documented, and definitively diagnosed World Health
- •Organization (WHO) grade 4, glioblastoma or lower grade malignant gliomas with
- •EGFRvIII positive tumor
- •* Must have recurrent disease confirmed by MRI (Group 1) or completed SoC
- •therapy such as surgery with adjuvant radiochemotherapy with or without
- •maintenance temozolomide according to local standards for newly diagnosed
- •disease (Group 2)
- •* Group 1 subjects must have * 1 index lesion by modified RANO criteria,
- •exemption: non-measurable disease is allowed for subjects with re-surgery
- •(surgery for recurrent disease) before start of screening
- •* Group 2 subjects must have radiographically measurable disease, or
- •non-measurable disease or both at the time of enrollment are allowedConfirmed
- •EGFRvIII positivity at time of study enrollment
- •* Hematological, hepatic and renal function as described in protocol page 35
排除标准
- •History or evidence of central nervous system bleeding within 6 months before
- •-Evidence of acute intracranial / intratumoral hemorrhage, except for subjects
- •stable grade 1 hemorrhage or fresh biopsy
- •-Known hypersensitivity to immunoglobulins or to any other component of the IP
- •formulation
- •-Prior malignancy (other than in situ cancer) unless treated with curative
- •and without evidence of disease for > 2 years before screening
- •-Infection requiring intravenous antibiotics that was completed < 1 week of
- •enrollment (day 1) with the exemption of prophylactic antibiotics for long line
- •insertion or biopsy
- •-Known positive test for human immunodeficiency virus (HIV)
- •-Active hepatitis B and C based on the following results:
- •-Unresolved toxicities from prior antitumor therapy, defined as not having
- •to CTCAE, version 4.0 grade 1
- •-Antitumor therapy (chemotherapy, antibody therapy, molecular-targeted therapy,
- •or investigational agent) within 14 days (Group 2 subjects) or 5 half-lives
- •(whichever is longer: for Group 1 subjects) of day 1. Avastin, Pembrolizumab
- •must be stopped 14 days prior to day 1.
- •-Treatment with nontopical systemic corticosteroids within 14 days before
- •enrollment (day 1)
- •-Major surgery within 7 days of study day 1 with the exception of biopsy and
- •line insertion
- •-Male and female of reproductive potential who are unwilling to practice an
- •highly effective method(s) of effective birth control
- •-Female who is pregnant or lactating/breastfeeding or who plans to be pregnant
- •or breastfeed
- •-Male who is unwilling to abstain from sperm donation while on study through 30
- •days after receiving the last dose of AMG 596 and through 4 months (120 days)
- •receiving the last dose of AMG 404.
- •The following Exclusion Criteria apply in addition for enrollment in
- •combination cohorts
- •with AMG 404:
- •History of solid organ transplantation.
- •Prior treatment with anti-PD-1, anti-PD-L1, CTLA-4 or other checkpoint inhibitor
- •Prior treatment with AMG 596 monotherapy arm is not eligible to enroll in the
- •combination therapy arm.
- •Live vaccine therapies within 4 weeks prior to study drug administration
- •Evidence of interstitial lung disease or active, non-infectious pneumonitis
- •History of any immune-related colitis.
- •Active or history of any autoimmune disease or immunodeficiencies.
- •Myocardial infarction within 6 months of study day 1, symptomatic congestive
- •heart failure (New York Heart Association > class II), unstable angina, or
- •arrhythmia requiring medication.
研究者
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