NCT03859752暂停1 期
A Phase 1, Open Label, First-in-human Study of TR1801-ADC, an Antibody Drug Conjugate (ADC), in Patients With Select Solid Tumors Expressing c-Met
Open Innovation Partners, Inc.8 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年8月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 15
- 试验地点
- 8
- 主要终点
- Establish maximum tolerated dose
研究概览
简要总结
First-in-human, Phase 1 study to assess safety, tolerability, and pharmacokinetics of TR1801-ADC in patients with select solid tumors that express c-Met.
详细描述
First-in-human, Phase 1, multiple dose-dose escalation study designed to determine safety, tolerability, maximum tolerated dose, and recommended phase 2 dose of TR1801-ADC in patients with select solid tumors that express c-Met. This study will also assess pharmacokinetics (PK), anti-tumor activity, and correlation between clinical outcomes (safety, anti-tumor activity, and PK) and c-Met expression.
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
- •Compliance with all study procedures and visits to the clinical research site
- •Locally advanced or metastatic disease that is not amenable to definitive therapy
- •Histologically confirmed diagnosis of a solid tumor which expresses c-Met
- •Must have progressed or have been intolerant to all available therapies known to confer clinical benefit appropriate for the patient's tumor type
- •Measurable baseline disease as defined by RECIST Version 1.1
- •ECOG Performance Status 0-1
- •Body weight within 40 and 150 kg
- •Clinical laboratory values with the limits as defined by the protocol
- •Not pregnant or breast feeding
- •Males and women of child-bearing potential must agree to use an effective method of contraception
排除标准
- •Any disease or condition that may be considered to pose an increased risk from study treatment or the ability of the patient to participate and comply with study procedures
- •Treatment with anti-cancer therapy (including cytotoxic chemotherapy, major surgery, radiation, biologic and investigational agents) within 21 days before first dose of study treatment
- •Brain metastases that has not stabilized for at least 28 days after therapy and who have discontinued steroids for <2 weeks
- •Unresolved adverse events >= Grade 2 from prior anticancer therapies
- •Acute myocardial infarction, cerebral ischemic infarct, or other arterial thrombosis within 6 months of screening for this study.
- •Uncontrolled hypertension, unstable angina, or NYHA Class III/IV heart failure
- •History of capillary leak syndrome
- •Corticosteroid intolerance
- •History of anasarca
- •Untreated or uncontrolled bacterial, viral or fungal infection
- •HIV infection or active infection with hepatitis B or C
- •Significant liver disease
- •History of alcoholism or current alcoholism
- •Signs of significant portal hypertension
- •Significant kidney disease within 2 years
- •Active or unstable gallstone disease
- •Prior treatment with a c-Met targeted agent
- •Prior hypersensitivity reaction to treatment with another monoclonal antibody
- •QTcF >=470 ms
- •Patients may not start any new herbal or dietary supplement within 4 weeks before initiation of study treatment nor while receiving study treatment
- •Administration of a live, attenuated vaccine within 28 days before the first dose of study treatment
结局指标
主要结局
Establish maximum tolerated dose
时间窗: 3.5 years
Number of participants with protocol-defined dose-limiting toxicity
Characterize safety of TR1801-ADC in patients with advanced solid tumor malignancies which express c-Met
时间窗: 4 years
Number of participants with treatment-related adverse events
次要结局
- Evaluate clinical activity of TR1801-ADC(5 years)
- Evaluate pharmacokinetics of TR1801-ADC(4 years)
- Immunogenicity(4 years)
研究者
研究点 (8)
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