A Phase 2, Multi-Center, Randomized, Open-Label Study of Two Dose Levels of IMOxine® (IMO-2055 for Injection) in Patients With Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Best Response by RECIST v1.0
研究概览
简要总结
- Multi-Center
- Randomized
- Open-Label Study of single agent IMO-2055
- Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)
详细描述
This is a study of 2 dose levels (0.16 or 0.64 mg/kg) of IMO-2055 administered by weekly subcutaneous (SC) injections in two patient populations, treatment naïve or previously treated patients. Each dose group (treatment naive or previously treated) will be randomized to receive one of the 2 doses being studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 stage IV clear cell renal carcinoma with metastatic or locally recurrent disease that is not surgically resectable.
- •At least one measurable lesion
- •Adequate organ function
- •Any prior treatment of renal cell cancer was concluded at least 4 weeks prior.
- •If female and of childbearing potential, a negative serum pregnancy test performed and documented no more than 14 days before the first dose of study drug.
排除标准
- •Known untreated central nervous system (CNS) metastasis
- •Pre-existing autoimmune or antibody-mediated diseases
- •Other significant medical disease.
研究组 & 干预措施
Previous treatment, 0.16mg/kg
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
干预措施: IMO-2055 (Drug)
Previous treatment, 0.64mg/kg
Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
干预措施: IMO-2055 (Drug)
Treatment Naive, 0.16mg/kg
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg
干预措施: IMO-2055 (Drug)
Treatment Naive, 0.64mg/kg
Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
干预措施: IMO-2055 (Drug)
结局指标
主要结局
Best Response by RECIST v1.0
时间窗: From start of treatment every 8 weeks (every 2 cycles), 1 month post-treatment, then every 3 months (up to 1 year) until documented disease progression or initiation of an alternative therapeutic treatment regimen.
Best overall objective (i.e., radiological) response by RECIST v1.0 for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR in patients with clear cell metastatic or locally recurrent renal cell carcinoma treated with IMO-2055.
次要结局
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) by National Cancer Institute (NCI) Grade/Severity(From start of treatment through one month after the end of study visit (up to 28 weeks))
- Duration of Response by RECIST v1.0(Every 8 weeks (2 cycles) from first response to documented disease progression during treatment, 1 month post-treatment, then every 3 months (up to 1 year) until documented disease progression or initiation of an alternative therapeutic treatment regimen.)
- Overall Survival at 1 Year(From date of randomization until the date of progression or date of death from any cause, whichever came first, asses up to 1 year after the last dose of study drug.)
- Time to Disease Progression.(Every 8 weeks (2 cycles) during the study and every 3 months for 1 year until documented disease progression)