NCT01417546已完成1 期
First In-Human Phase I Trial of NHS-IL12 in Patients With Metastatic Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicities (DLTs) and Maximum Tolerated Dose (MTD)
研究概览
简要总结
Background:
- The experimental drug NHS-IL12 may help the immune system become more active and kill cancer cells that have not responded to standard treatments. NHS-IL12 has been designed to cause less severe side effects than other anticancer drugs, and may be more effective. More research is needed to test NHS-IL12 in people who have solid tumors that have not responded to treatment.
Objectives:
- To test the safety and effectiveness of NHS-IL12 as a treatment for solid tumors which have not responded to standard treatments.
Eligibility:
- Individuals at least 18 years of age with solid tumors that have not responded to standard treatments.
Design:
- Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies.
- Participants will receive NHS-IL12 injection every 4 weeks, and will stay in the hospital for at least one day to be monitored with frequent blood tests.
- Participants will have periodic blood samples taken before treatment and during the first week after treatment for the first two cycles. They will then have blood samples taken before treatment for the rest of the cycles.
详细描述
Background:
- Interleukin-12 (IL-12) is a proinflammatory cytokine produced by activated phagocytes and dendritic cells (DCs) that plays a critical role in regulating the transition from innate to adaptive immunity.
- IL-12 has shown some promising clinical activity in phase I trials, including stabilization of disease in renal cancer patients with partial regression of a metastatic lesion, but has not proceeded further in clinical development due to toxicity.
- The NHS-IL12 concept is a strategy to reduce the toxicity associated with systemic administration of recombinant human IL-12 by selectively targeting delivery to tumors. The NHS-IL12 immunocytokine is composed of 2 IL-12 heterodimers, each fused to one of the H-chains of the NHS76 antibody, which has affinity for both single- and doublestranded DNA. Thus, NHS-IL12 targets delivery to regions of tumor necrosis where DNA has become exposed.
Objectives:
-To determine the dose-limiting toxicities (DLTs) and Maximum Tolerated Dose (MTD) of NHS-IL12 administered subcutaneously every 4 weeks and subcutaneously every 2 weeks in participants with metastatic or locally advanced solid epithelial or mesenchymal tumors.
Eligibility:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
NHS-IL12 escalating doses on a 4 week schedule (Completed).
干预措施: NHS-IL-12 (Drug)
2
Experimental
NHS-IL12 escalating doses on a 2 week schedule
干预措施: NHS-IL-12 (Drug)
3
Experimental
NHS-IL12 expansion group on a 4 week schedule (Completed).
干预措施: NHS-IL-12 (Drug)
结局指标
主要结局
Dose-limiting toxicities (DLTs) and Maximum Tolerated Dose (MTD)
时间窗: During the first 6 weeks or at least 2 weeks after administration of the second dose.
Determination of DLTs and MTD.
次要结局
- To determine immunogenicity, safety and pharmacokinetic parameters(Ongoing)
研究者
研究点 (1)
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