EUCTR2011-001282-40-DE进行中（未招募）1 期
A Study of the Efficacy and PK/PD Relationship of Monotherapy MORAb-004 in Subjects with Metastatic Melanoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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] At least 18 years of age
- •[2] Surgically sterile or who consent to use a medically acceptable method of contraception throughout the study period
- •[3] Histologically confirmed diagnosis of metastatic cutaneous (nonocular, nonmucosal) melanoma
- •[4] At least one prior systemic treatment for metastatic melanoma with disease progression following treatment
- •[5] Measurable disease, as defined by RECIST v.1.1, assessed within 4 weeks prior to study entry
- •[6] Prior anticancer therapy (chemotherapy, immunotherapy, or radiation therapy) must have been completed at least 3 weeks (21 days) prior to starting MORAb-004
- •therapy, and all treatment-associated toxicity must be resolved to Grade 1 or less before the first infusion of study drug (MORAb-004)
- •[7] Life expectancy of at least 3 months as estimated by the investigator
- •[8] Any other significant medical conditions well-controlled and stable, in the opinion of the investigator, for at least 30 days prior to Study Day 1
- •[9] ECOG Performance Status of 0 or 1 at screening
- •[10] Disease sites amenable to protocol-specified tissue biopsy (Note: All subjects will have protocol-specified biopsy at screening. The second, on-treatment biopsy will be required in the first 30 randomized subjects and is optional for all subsequently randomized subjects.)[11] Willingness and ability to provide written informed consent
- •[12] Laboratory test results within 14 days prior to Study Day 1: Absolute neutrophil count at least 1.5×10^9/L; Platelet count at least 100 × 10^9/L; Hemoglobin at least 8 g/dL; Creatinine no greater than 1.5 × ULN (NCI CTCAE Grade 1); Bilirubin less than 1.5 × ULN (NCI CTCAE Grade 1); Aspartate aminotransferase and alkaline phosphatase less than 2.5 × ULN (NCI CTCAE Grade 1); Activated partial thromboplastin time (aPTT) and prothrombin time (PT) less than 1.5 × ULN (NCI CTCAE Grade 1)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 56
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •[1] No prior systemic treatment for metastatic melanoma
- •[2] Evidence of active malignancy other than metastatic melanoma requiring treatment within the last 5 years (other than basal cell or squamous cell skin cancer)
- •[3] Clinically significant heart disease
- •[4] ECG demonstrating clinically significant arrhythmia
- •[5] Any other serious systemic disease, including active bacterial or fungal infection, or any medical condition requiring cytotoxic therapy or chronic use of systemic corticosteroids (use for at least 4 consecutive weeks)
- •[6] Active viral hepatitis or symptomatic HIV infection (Asymptomatic positive serology is not exclusionary.)
- •[7] Breast-feeding, pregnant, or likely to become pregnant during the study
- •[8] Known allergic reaction to a prior monoclonal antibody therapy
- •[9] Previous treatment with MORAb-004 (anti-TEM-1)
- •[10] Any evidence of brain metastasis
研究者
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