A Phase 1a Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of OMP-336B11 Administered as a Single Agent to Subjects With Locally Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-336B11
研究概览
简要总结
The purpose of this study is to test the safety and efficacy of OMP-336B11. OMP-336B11 is an engineered human protein that was designed to bind to the GITR receptor on T cells and activate the immune system to recognize and eliminate cancer cells.
详细描述
This is an open-label, Phase 1a dose escalation study of OMP-336B11 administered as a single agent to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with locally advanced or metastatic tumors. 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 approximately 2 years. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Locally advanced or metastatic solid tumors that have exhausted standard of care therapy
- •Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1
- •Age >21 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate organ and marrow function
- •For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit.
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Receiving any other investigational agents or any other anti-cancer therapy
- •Active autoimmune disease or a history of severe autoimmune disease or syndrome
- •History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •Pregnancy, lactating or breastfeeding women
- •History of primary CNS malignancy, or leptomeningeal disease or CNS metastases
- •Significant uncontrolled intercurrent illness that will limit the patient's ability to participate in the study
- •Inability to comply with study and follow up procedures
研究组 & 干预措施
OMP-336B11
Intravenous (in the vein) infusions of OMP-336B11
干预措施: OMP-336B11 (Drug)
结局指标
主要结局
The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-336B11
时间窗: Subjects will be assessed for DLTs through the end of the first cycle (Days 1-29)
Incidence of dose limiting toxicities (DLTs)
次要结局
- Pharmacokinetic Outcome Measures (CL)(Screening through 12 weeks post treatment termination)
- Pharmacokinetic Outcome Measures (Vd)(Screening through 12 weeks post treatment termination)
- Pharmacokinetic Outcome Measures (T1/2)(Screening through 12 weeks post treatment termination)
- Immunogenicity of OMP-336B11 (Percentage of patients with anti-336B11 antibodies)(up to approximately 2 years)
- Progression-Free Survival(up to approximately 2 years)
- Objective Response(up to approximately 2 years)