A Phase 1b Dose Escalation Study of Vantictumab (OMP-18R5) in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Stage IV Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Phase 1b: Safety and tolerability of vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer
研究概览
简要总结
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with nab-paclitaxel and gemcitabine.
详细描述
Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined, up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the safety, tolerability and PK of vantictumab combined with nab-paclitaxel and gemcitabine. Up to approximately 34 patients may be enrolled into 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form
- •Age ≥18 years
- •Histologically documented Stage IV ductal adenocarcinoma of the pancreas
- •Availability of tumor tissue, either archival FFPE or obtained at study entry through fresh biopsy
- •ECOG performance status of 0 or 1
- •Adequate hematologic and end-organ function
- •Evaluable or measurable disease per RECIST v1.1
- •For women of childbearing potential and men with partners of childbearing potential, agreement to use two effective forms of contraception
排除标准
- •Prior therapy before Day 1 of Cycle 1 for the treatment of Stage IV pancreatic cancer
- •Prior adjuvant therapy for the treatment of ductal adenocarcinoma of the pancreas
- •Known hypersensitivity to any component of study treatments
- •Known brain metastases, uncontrolled seizure disorder, or active neurologic disease
研究组 & 干预措施
Vanctictumab (OMP-18R5)
Vantictumab will be administered by intravenous (IV) infusion.
干预措施: Vantictumab (Drug)
Vanctictumab (OMP-18R5)
Vantictumab will be administered by intravenous (IV) infusion.
干预措施: Nab-Paclitaxel (Drug)
Vanctictumab (OMP-18R5)
Vantictumab will be administered by intravenous (IV) infusion.
干预措施: Gemcitabine (Drug)
Nab-Paclitaxel
Nab-Paclitaxel will be administered by intravenous (IV) infusion.
干预措施: Vantictumab (Drug)
Nab-Paclitaxel
Nab-Paclitaxel will be administered by intravenous (IV) infusion.
干预措施: Nab-Paclitaxel (Drug)
Nab-Paclitaxel
Nab-Paclitaxel will be administered by intravenous (IV) infusion.
干预措施: Gemcitabine (Drug)
Gemcitabine
Gemcitabine will be administered by intravenous (IV) infusion.
干预措施: Vantictumab (Drug)
Gemcitabine
Gemcitabine will be administered by intravenous (IV) infusion.
干预措施: Nab-Paclitaxel (Drug)
Gemcitabine
Gemcitabine will be administered by intravenous (IV) infusion.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Phase 1b: Safety and tolerability of vantictumab in combination with nab-paclitaxel and gemcitabine in patients with previously untreated Stage IV pancreatic cancer
时间窗: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28)
The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with weekly nab-paclitaxel
次要结局
- Pharmacokinetics (PK) of vantictumab when administered in combination with nab-paclitaxel and gemcitabine to patients with previously untreated Stage IV pancreatic cancer(Vantictumab will be administered IV on Days 1 and 15 of each 28-day cycle. Nab-paclitaxel and gemcitabine will be administered IV on Days 1, 8, and 15 of each cycle.)