A Phase 2, Open-Label Study to Evaluate the Safety and Antitumor Activity of Praluzatamab Ravtansine (CX-2009) in Advanced HR-Positive/HER2-Negative Breast Cancer and of Praluzatamab Ravtansine as Monotherapy and in Combination With Pacmilimab (CX-072) in Advanced Triple-Negative Breast Cancer (CTMX-2009-002)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 42
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
A Phase 2, clinical study in advanced, metastatic breast cancer that will evaluate CX-2009 monotherapy in both Hormone Receptor(HR) positive/HER2 negative breast cancer and in TNBC, and evaluate CX-2009+CX-072 in TNBC
详细描述
Eligible patients will be enrolled to the treatment arm based on breast cancer subtype.
Patients will receive study treatment on Day 1 of a Q3W cycle. Treatment with CX-2009 monotherapy (Arms A and B) or CX-2009 in combination with CX-072 (Arm C) will be given until disease progression or symptomatic deterioration, unacceptable toxicity necessitating treatment discontinuation, or if the patient meets certain study defined criteria for discontinuation. On-treatment tumor assessments, will occur every 6 weeks per RECIST v1.1 for the first 48 weeks, and every 12 weeks thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ARM A - CX-2009 Monotherapy, HR-positive/HER2-negative
CX-2009 Monotherapy in advanced, metastatic Hormone Receptor (HR)-positive / Human Epidermal growth factor Receptor 2 (HER2)-negative breast cancer
干预措施: CX-2009 (Drug)
ARM B - CX-2009 Monotherapy, TNBC
CX-2009 Monotherapy in advanced, metastatic Triple-Negative Breast Cancer (TNBC)
干预措施: CX-2009 (Drug)
ARM C - CX-2009 Combination therapy, TNBC
CX-2009 and CX-072 Combination therapy in advanced, metastatic TNBC
干预措施: CX-2009 (Drug)
ARM C - CX-2009 Combination therapy, TNBC
CX-2009 and CX-072 Combination therapy in advanced, metastatic TNBC
干预措施: CX-072 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 30 months
ORR is the proportion of patients in the efficacy-evaluable population with a best response of Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Central Radiology Review (CRR)
次要结局
- Clinical Benefit Rate (CBR) at 16 Weeks(30 Months)
- Duration of Response (DoR)(30 Months)
- Overall Survival (OS)(30 Months)
- Clinical Benefit Rate (CBR) at 24 Weeks(30 Months)
- Investigator-assessed Progression-Free Survival (PFS)(30 Months)