Phase 1 Trial of a Monoclonal Antibody to OX40 in Patients With Advanced Cancer.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Dose limiting toxicity
研究概览
简要总结
This study is designed to determine the safety and highest tolerated dose of anti-OX40 in patients with advanced cancer.
详细描述
This study will evaluate the safety and determine the maximal tolerated dose of anti-OX40; evaluated the immune response to the study treatment; measure the pharmacokinetics of anti-OX40; monitor tumor regression, and identify the most biologically active dose of anti-OX40 to induce antigen-specific responses to a variety of immunogens.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Patients with uncurable metastatic carcinoma, lymphoma, or sarcoma.
- •ECOG performance status 0, 1, 2
- •No active bleeding
- •No clinical coagulopathy
- •Anticipated lifespan greater than 12 weeks
排除标准
- •Active residual toxicity from prior therapies
- •Active Infection
- •HIV positive
- •Hepatitis B or C positive
- •Pregnant or nursing women
- •Requirement for oral steroids
- •Brain metastases
- •Presence or history of autoimmune disease
- •Shellfish or tetanus allergy
- •Splenomegaly
- •Lymph nodes greater than 10 cm in maximal diameter
- •Uncontrolled angina or class II or IV heart failure
研究组 & 干预措施
Tetanus vaccine + anti-OX40
Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH
干预措施: Cohort 3 anti-OX40 (Drug)
KLH + anti-OX40
Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine
干预措施: Cohort 1 anti-OX40 (Drug)
KLH + anti-OX40
Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine
干预措施: Cohort 2 anti-OX40 (Drug)
KLH + anti-OX40
Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine
干预措施: Cohort 3 anti-OX40 (Drug)
KLH + anti-OX40
Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine
干预措施: Tetanus Day 29 (Biological)
Tetanus vaccine + anti-OX40
Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH
干预措施: Cohort 1 anti-OX40 (Drug)
Tetanus vaccine + anti-OX40
Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH
干预措施: Cohort 2 anti-OX40 (Drug)
KLH + anti-OX40
Day 1: KLH + anti-OX40; Day 3: anti-OX40; Day 4: anti-OX40; Day 29: Tetanus vaccine
干预措施: KLH Day 1 (Biological)
Tetanus vaccine + anti-OX40
Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH
干预措施: Tetanus Day 1 (Biological)
Tetanus vaccine + anti-OX40
Day 1: Tetanus vaccine + anti-OX40; Day 3: anti-OX40; Day 5: anti-OX40; Day 29: KLH
干预措施: KLH Day 29 (Biological)
结局指标
主要结局
Dose limiting toxicity
时间窗: 28 Days
A dose limiting toxicity is defined as any grade \>=3 hematologic (except lymphopenia) or non-hematologic toxicity (except hypothyroidism or vitiligo) that, in the opinion of the investigator is considered at lease possibly related to the study treatment. If DLT is observed in greater than two patient in any cohort, then the previous cohort will be the maximal tolerated dose.
次要结局
- Immune Response(Pre-study, Days 5, 8, 15, 29, 36, 43, and 57.)