NCT00689065终止1 期
A Phase I, Dose-Escalating Study of the Safety of Intravenous CALAA-01 in Adults With Solid Tumors Refractory to Standard-of-Care Therapies
Calando Pharmaceuticals3 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2008年5月最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- To determine the tolerability, safety profile and maximum tolerated dose (MTD) of intravenous CALAA-01.
研究概览
简要总结
Rationale: CALAA-01 is a targeted therapeutic designed to inhibit tumor growth and/or reduce tumor size. The active ingredient in CALAA-01 is a small interfering RNA (siRNA). This siRNA inhibits tumor growth via RNA interference to reduce expression of the M2 subunit of ribonucleotide reductase (R2). The CALAA-01 siRNA is protected from nuclease degradation within a stabilized nanoparticle targeted to tumor cells.
PURPOSE: This phase I trial will:
- Determine the safety, toxicity, and the maximum tolerated dose (MTD) of CALAA-01 when administered intravenously to patients with relapsed or refractory cancer.
- Characterize the pharmacokinetics (PK) of CALAA-01 after intravenous administration.
- Provide preliminary evidence of efficacy of intravenous CALAA-01 by evaluating tumor response.
- Recommend a dose of intravenous CALAA-01 for future clinical studies.
- Evaluate immune response, by measuring antibody and cytokine levels, and the effect of intravenous CALAA-01 on complement.
详细描述
CALAA-01 is a targeted nanocomplex that contains anti-R2 siRNA. The complete nanocomplex formulation consists of four components:
- a duplex of synthetic, non-chemically-modified siRNA (C05C)
- a cyclodextrin-containing polymer (CAL101),
- a stabilizing agent (AD-PEG), and
- a targeting agent (AD-PEG-Tf) that contains the human transferrin protein (Tf). The cationic polymer interacts electrostatically with anionic siRNA to assemble into nanocomplexes below approximately 100 nm in diameter that protect the siRNA from nuclease degradation in serum. The siRNA-containing nanocomplexes are targeted to cells that over express the transferrin receptor (TfR). Upon reaching a target cell, transferrin binds to TfRs on the cell surface and the siRNA-containing nanocomplex enters the cell by endocytosis. Inside the cell, chemistry built into the polymer achieves unpackaging of the siRNA from the nanocomplex, permitting it to function via RNA interference.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CALAA-01
Experimental
干预措施: CALAA-01 (Drug)
结局指标
主要结局
To determine the tolerability, safety profile and maximum tolerated dose (MTD) of intravenous CALAA-01.
时间窗: 3 months
次要结局
- To characterize the pharmacokinetics (PK) of CALAA-01 after intravenous administration.(3 Months)
- To determine preliminary efficacy of intravenous CALAA-01 by evaluating tumor response.(3 months)
- To recommend an intravenous dose of CALAA-01 for future clinical studies.(3 month)
- To evaluate immune response, by measuring antibody and cytokine levels, and effect of intravenous CALAA-01 on complement.(3 month)
研究者
研究点 (3)
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