NCT03783403进行中（未招募）1 期
A Phase 1, Open-label, Dose Finding Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, Alone and in Combination With Cetuximab or Rituximab in Subjects With Advanced Solid and Hematologic Cancers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Celgene
- 入组人数
- 230
- 试验地点
- 31
- 主要终点
- Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 as a single agent and in combination with cetuximab and rituximab in participants with advanced solid and hematologic cancers.
详细描述
This is a test.
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
- •Progressed on standard anticancer therapy or for whom no other approved conventional therapy exists and have histological or cytological confirmation of advanced unresectable solid tumors, advanced unresectable colorectal cancer, or squamous cell carcinoma of the head and neck, or CD20-positive non-Hodgkin's lymphoma, or diffuse large B cell lymphoma, or follicular lymphoma
- •Solid tumors must have at least one site of measurable disease as determined by RECIST v1.1
- •Eastern cooperative oncology group performance status of 0 or 1
排除标准
- •High-grade lymphomas (Burkitt's or lymphoblastic)
- •Has cancer with symptomatic central nervous system (CNS) involvement
- •History of class III or IV congestive heart failure (CHF) or severe non-ischemic cardiomyopathy, unstable angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
CC-95251 in combination with cetuximab
Experimental
干预措施: CC-95251 (Drug)
CC-95251
Experimental
干预措施: CC-95251 (Drug)
CC-95251 in combination with rituximab
Experimental
干预措施: CC-95251 (Drug)
CC-95251 in combination with rituximab
Experimental
干预措施: Rituximab (Drug)
CC-95251 in combination with cetuximab
Experimental
干预措施: Cetuximab (Drug)
结局指标
主要结局
Non-Tolerated Dose (NTD): A dose that causes unacceptable side effects
时间窗: 18 months
Maximum Tolerated Dose (MTD): The highest dose that does not cause unacceptable side effects
时间窗: 18 months
Dose-Limiting Toxicity (DLT): Any adverse events meeting the protocol-defined DLT criteria
时间窗: 30 months
次要结局
- Overall response rate (ORR): The percent of participants whose best response is complete response (CR) or partial response (PR)(72 Months)
- Overall survival (OS): Time from the first dose to death due to any cause(66 Months)
- Pharmacokinetic - Maximum serum concentration of the drug (Cmax)(36 Months)
- Pharmacokinetic - Minimum serum concentration of the drug (Cmin)(36 Months)
- Pharmacokinetic - Area under the serum concentration time-curve of the drug (AUC)(36 Months)
- Anti-CC-95251 antibody (ADA) assessment: determine the presence and frequency of anti-drug antibodies(36 Months)
- Time to response (TTR): Time from the first dose to the first objective tumor response observed for participants who achieved a CR or PR(66 Months)
- Progression free survival (PFS): Time from the first dose to the first occurrence of disease progression or death from any cause(66 Months)
- Duration of response (DOR): Time from the first objective tumor response observed for participants who achieved a CR or PR until the first date at progressive disease is objectively documented(66 Months)
研究者
研究点 (31)
Loading locations...
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