临床试验/NCT01123304

NCT01123304终止1 期

A Phase 1 Clinical Trial of Intra-Tumoral Injection of Human IgM Monoclonal Antibody (MORAb-028) to the Ganglioside GD2 in Subjects With Injectable Metastatic Melanoma

Morphotek1 个研究点分布在 1 个国家目标入组 18 人开始时间: 2010年5月最近更新: 2014年7月17日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方: Morphotek
入组人数: 18
试验地点: 1
主要终点: Safety of multiple intralesional administration of MORAb-028

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This research is being done to find out the safety of MORAb-028 in subjects with metastatic melanoma.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Histologically confirmed AJCC Stage IIIB, IIIC or IV melanoma with injectable metastases (in transit, intradermal, or subcutaneous nodules)
•Tumor accessible to intra-tumoral injections
•Cumulative tumor volume great enough to accept MORAb-028 injections for a given dose level, based on intent to inject at a concentration of 1 mg/cm3

排除标准

•Are candidates for curative surgical excision or lymphadenectomy
•Prior non-surgical treatment within 4 weeks
•Known central nervous system (CNS) tumor involvement or metastases
•Hypersensitivity to MORAb-028

研究组 & 干预措施

MORAb 028

Experimental

干预措施: MORAb028 (Drug)

结局指标

主要结局

Safety of multiple intralesional administration of MORAb-028

时间窗: Day 33

After each patient completes study treatment the patient is evaluated for dose limiting toxicities (DLTs) up to 1 week after their last dose (at day 33)

次要结局

Maximum tolerated dose of intralesional administration of MORAb-028(22 months)

研究者

发起方

Morphotek

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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