Phase I/II Open Label Dose Escalation and Dose Expansion Study of Intravenous Infusion of W0101, an Antibody-drug Conjugate, in Patients with Advanced or Metastatic Solid Tumors. International, Multicenter, Open Label Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 316
- 试验地点
- 3
- 主要终点
- Incidence of Specific Adverse Events
研究概览
简要总结
W0101 combines a cytotoxic compound to a monoclonal antibody targeting a receptor commonly overexpressed in many cancers.
The development of antibody-drug conjugates takes advantage of the specificity of the mAb while augmenting its ability to produce a cytotoxic effect. The expected benefits of antibody-drug conjugation are enhancement of cytotoxicity in target cells and limiting toxicities of cytotoxic drugs in normal tissues.
详细描述
This is a First In Human study, multicenter, open label study divided into 2 parts: an initial dose escalation phase (I) followed by expansion cohort(s) phase (II).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Dose escalation phase (cohort A1 and A2)
- •Male or female subjects age ≥ 18 years
- •Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors (excluding lymphoma) , unresponsive to standard treatment or for whom no standard treatment is available or appropriate
- •ECOG performance status 0 or 1
- •Adequate bone marrow, renal, hepatic at screening and at Baseline
- •Subject must have measurable diseases as per RECIST v1.1 criteria
排除标准
- •Symptomatic brain metastases, CNS tumors
- •Symptomatic motor or sensory peripheral neuropathy (≥ grade 2)
- •Subjects having ophthalmologic abnormalities
- •Active serious systemic disease (infection,organic or dysmetabolic desease)
- •Left ventricular ejection fraction (LVEF) < 45% as determined by MUGA scan or echography at screening
- •QTc > 470 msec on screening ECG or congenital long QT syndrome
- •Biologic therapy (including ADCs ≤ 4 weeks before first study treatment administration)
研究组 & 干预措施
W0101 - Cohort A2
This is a 21 days treatment cycle cohort in a 3 weeks schedule
干预措施: W0101 - Cohort A2 (Drug)
W0101 - Cohort A1
This is a 14 days treatment cycle cohort in a 2 weeks schedule
干预措施: W0101 - Cohort A1 (Drug)
W0101 - Expansion Phase
Will be initiated after completion of cohorts A1 and A2
干预措施: W0101 - Expansion Phase (Drug)
结局指标
主要结局
Incidence of Specific Adverse Events
时间窗: From first administration up to 63 days
Identification of Dose-limiting toxicities
次要结局
未报告次要终点