A Phase Ib/II Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-muscle Invasive Bladder Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 5
- 主要终点
- Safety Profile
研究概览
简要总结
This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of ALT-801 combined with gemcitabine for patients who have BCG failure (defined as refractory, relapsing or intolerant), non-muscle invasive bladder cancer and refuse or are not medically fit to undergo a radical cystectomy recommended by the participating urologist as the standard next therapy per urologic guidelines. The purpose of this study is to confirm the safety and tolerability of a well-tolerated dose level of ALT-801, to determine the Recommended Dose level (RD) and characterize the immunogenicity of ALT-801 combined with gemcitabine in treated patients. The anti-tumor responses will also be assessed.
详细描述
Bladder cancer is the fifth most common cancer in the United States with an estimated 71,000 new cases and approximately 14,000 deaths in 2009. Bladder cancer is also the costliest to treat per patient of all cancers, with annual direct medical expenditures in excess of $3.7 billion in the United States. This is largely because approximately 70% of all new cases of bladder cancer present as non-muscle invasive bladder cancer (NMIBC), which tends to recur, requiring repeated interventions and long-term follow-up.
Altor Bioscience Corp. has developed a tumor-targeted IL-2 fusion protein, ALT-801, comprising human recombinant IL-2 genetically linked to a TCR domain capable of binding a tumor associated human p53 peptide presented in the context of HLA-A2.
ALT-801 will be evaluated as to whether it can prevent disease progression and allow for bladder preservation to maintain the quality of life for patients with BCG failure, defined as refractory, relapsing or intolerant, non-muscle invasive bladder cancer who refuse or are not medically fit to undergo a radical cystectomy recommended by the participating urologist as the standard next therapy per urologic guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
0.06 mg/kg ALT-801 with 1000 mg/m^2 Gemcitabine
ALT-801 at 0.06 mg/kg with Gemcitabine at 1000 mg/m^2
干预措施: ALT-801 (Biological)
0.06 mg/kg ALT-801 with 1000 mg/m^2 Gemcitabine
ALT-801 at 0.06 mg/kg with Gemcitabine at 1000 mg/m^2
干预措施: Gemcitabine (Drug)
0.08 mg/kg ALT-801 with 1000 mg/m^2 Gemcitabine
ALT-801 at 0.08 mg/kg with Gemcitabine at 1000 mg/m^2
干预措施: ALT-801 (Biological)
0.08 mg/kg ALT-801 with 1000 mg/m^2 Gemcitabine
ALT-801 at 0.08 mg/kg with Gemcitabine at 1000 mg/m^2
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Safety Profile
时间窗: 12 weeks
Confirmation of the safety and tolerability (dose limiting toxicity count) of ALT-801 combined with gemcitabine.
Disease Response Rate
时间窗: From start of study treatment to up to 13 weeks
The response rate was calculated as the ratio of the number of patients who demonstrated a complete response (by RECIST v1.1) divided by the number of patients evaluable for response. A complete response was defined as having negative bladder biopsy results.
次要结局
- Duration of Response(From confirmed complete response to up to 3 years)
- Progression-free Survival(From start of study treatment to up to 3 years)
- Event-free Survival(From start of study treatment to up to 3 years)
- Overall Survival(From start of study treatment to up to 3 years)