A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in Combination With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 5
- 主要终点
- Percentage of patients with dose limiting toxicities
研究概览
简要总结
A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in Combination with Chemotherapy for Subjects with Previously Treated Metastatic Colorectal Cancer.
详细描述
This is a phase 1b dose escalation study of the safety and pharmacodynamics of brontictuzumab in combination with chemotherapy for subjects with previously treated metastatic colorectal cancer. This study consists of a screening period, a treatment period and a post-treatment follow up period in which patients will be followed for survival for up to 24 months. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.
Approximately 34 patients will be enrolled in this study at approximately 5 study centers in the United States.
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
- •Histologically confirmed metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if KRAS wild-type, an anti-EGFR therapy
- •ECOG performance status 0 or 1
排除标准
- •Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors
- •Subjects with known active HIV infection. Subjects with HIV that are under a stable anti-retroviral regimen and have no evidence of immune deficiency (normal CD4 counts), undetectable viral load, and no HIV-related infections are eligible
- •Subjects with uncontrolled diarrhea <30 days prior to first administration of study drug
- •Subjects with any history of or current clinically significant gastrointestinal disease including, but not limited to:
- •Inflammatory bowel disease (including ulcerative colitis and Crohn's disease)
- •Active peptic ulcer disease
- •Known intraluminal metastatic lesion(s) with risk of bleeding
研究组 & 干预措施
Brontictuzumab and trifluridine/tipiracil
Brontictuzumab will be administered per protocol and trifluridine/tipiracil per label.
干预措施: brontictuzumab (Drug)
Brontictuzumab and trifluridine/tipiracil
Brontictuzumab will be administered per protocol and trifluridine/tipiracil per label.
干预措施: trifluridine/tipiracil (Drug)
结局指标
主要结局
Percentage of patients with dose limiting toxicities
时间窗: 28 days
Percentage of patients with anti-brontictuzumab antibodies
时间窗: up to approximately 2 years
Percentage of patients with adverse events
时间窗: up to approximately 2 years
次要结局
- Objective Response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)(approximately 2 years)
- Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1(approximately 2 years)
- Changes in number of circulating tumor cells(approximately 2 years)
- Overall survival(approximately 2 years)