An Open-label, Dose-escalation and Expansion Phase 1/2a Clinical Trial to Assess the Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and the Anti-tumor Efficacy of NOV1501 (ABL001) in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
研究概览
简要总结
The purpose of this open-label, dose escalation-dose expansion, Phase 1 clinical trial is to evaluate the safety, pharmacokinetics and anti-tumor activity and determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of NOV1501 (ABL001).
详细描述
This is an open-label, Phase 1 dose escalation and expansion study of NOV1501 (ABL001) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and the anti-tumor efficacy of ABL001 in patients with advanced solid tumors after failure of standard of care.
Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase. DLTs will be assessed as the primary endpoint in this trial.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥19 year old patients with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors
- •Lesions measured by tumor markers or by CT/MRI must be evaluable based on response evaluation criteria in solid tumors (RECIST) version 1.
- •Life expectancy ≥12 weeks
- •ECOG performance status ≤2
- •Women of childbearing potential must have a negative pregnancy test outcome
- •Patients must provide written informed consent to voluntary participation in this study.
排除标准
- •History of hypersensitivity reactions to any of the components of the investigational product or other drugs of the same class
- •Less than 4 weeks have elapsed since a major surgery and 2 weeks have elapsed since a minor surgery
- •New York Heart Association (NYHA) class ≥II congestive heart failure (CHF)
- •Persistent, clinically significant NCI-CTCAE v4.03 Grade ≥2 toxicities from the previous anticancer therapy
- •Severe infections or severe traumatic systemic disorders
- •Symptomatic or uncontrolled central nervous system (CNS) metastasis
- •Pregnant or lactating women or patients planning to become pregnant during the study
- •Participation in another clinical trial within 30 days prior to screening
- •Administration of antiplatelets or anticoagulants within 2 weeks prior to screening
- •Requiring continuous treatment with systemic NSAIDs or systemic corticosteroids
- •HIV or other severe diseases that warrant the exclusion from this study
- •Peritoneal and/or pleural fluid drainage within 28 days prior to screening
- •History of hemoptysis within 28 days prior to screening
- •Serious, untreated scar, active ulcer, or untreated fracture
研究组 & 干预措施
NOV150101 (ABL001)
干预措施: NOV1501 (ABL001) (Drug)
结局指标
主要结局
Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
时间窗: From time of 1st administration of ABL001 until day 21.
The maximum tolerated dose/maximum administered dose will be determined by the number of participant experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.
次要结局
未报告次要终点