NCT00043407已完成1 期
A Phase I/II, Open Label, Multi-Center Study For The Evaluation Of CPG 7909 In Patients With Stage Iv Renal Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 42
- 主要终点
- To determine the tolerability of escalating doses of subcutaneously administered CPG 7909 Injection up to a maximum dose of 0.81 mg/kg in patients with metastatic renal cell cancer.
研究概览
简要总结
CPG 7909 given alone to patients with renal cell cancer after their nephrectomy. CPG 7909 is as a subcutaneous injection once per week for up to 24 weeks. Up to 40 patients will be included in the study.
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
- •Stage IV Renal Cell Carcinoma with lung and/or soft tissue metastasis Nephrectomy Measurable disease by RECIST criteria
排除标准
- •CNS, bone or Liver metastasis Tumors that are mainly papillary, chromophobe, medullary, collecting duct, or unclassified Prior immunotherapy, including IL-2 or IFN-alpha
研究组 & 干预措施
CPG 7909 Injection
Experimental
干预措施: CPG 7909 (Drug)
结局指标
主要结局
To determine the tolerability of escalating doses of subcutaneously administered CPG 7909 Injection up to a maximum dose of 0.81 mg/kg in patients with metastatic renal cell cancer.
时间窗: Indeterminate
To establish the maximum tolerated dose for CPG 7909 Injection as monotherapy in patients with metastatic renal cell cancer up to a dose of 0.81mg/kg.
时间窗: Indeterminate
To estimate the overall tumor response rate of CpG 7909 according to the RECIST criteria in patients with metastatic renal cell cancer.
时间窗: Indeterminate
次要结局
- To assess tolerability relative to dose exposure, immunologic activity, the pharmacokinetic and pharmacodynamic profile of CPG 7909 Injection, time to progression, duration of response, and time to survival.(Indeterminate)
研究者
相似试验
已完成
1 期
CPG 7909 in Patients With Cutaneous T-Cell LymphomaLymphoma, T-Cell, CutaneousNCT00043420Pfizer42
尚未招募
2 期
A Study of Sintilimab in Combination With Axitinib in Advanced Renal Cell CancerRenal Cell CarcinomaClear Cell Renal Cell CarcinomaNCT04958473Tianjin Medical University Second Hospital40
已完成
2 期
Clinical Trial on the Mixture of G, C and S in Treatment of Patients With RCCCarcinoma, Renal CellNCT00496301Spanish Oncology Genito-Urinary Group40
暂停
1 期
68Ga-NYM096/177Lu-NYM096 in Metastatic ccRCCClear Cell Renal Cell CarcinomaNCT06649682Peking Union Medical College Hospital20
招募中
1 期
A Study of GNC-039, a Tetra-specific Antibody, in Participants With Relapsed/Refractory or Metastatic Solid TumorsRecurrent GliomaSolid TumorNCT04794972Sichuan Baili Pharmaceutical Co., Ltd.60