NCT03317743已完成1 期
Open-label, Phase I Clinical Trial to Identify Optimal Dose and Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Anti-cancer Efficacy of NOV140101(IDX-1197HCl) in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 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 NOV140101 (IDX-1197).
详细描述
This is an open-label, Phase 1 dose escalation study of NOV140101 (IDX-1197) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and the anti-tumor efficacy of IDX-1197 in patients with advanced solid tumors after failure of standard of care. 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
- •Life expectancy ≥12 weeks
- •Women of childbearing potential must have a negative pregnancy test outcome
- •ECOG performance status ≤2
- •Lesions measured by tumor markers or CT/MRI and evaluable according to RECIST v1.1
- •Patient must have adequate organ function as indicated by the following laboratory values independent of transfusion within 2 weeks:
- •ANC ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 9.0g/dL
- •Serum creatinine ≤ 1.5×ULN
- •Total bilirubin ≤ 1.5×ULN
- •AST, ALT ≤ 3×ULN (≤ 5×ULN for patients with liver metastasis or liver cell cancer)
- •PT and aPTT ≤ 1.5×ULN
- •UPC < 1.0 g/g (one re-test is allowed if positive (≥ 1))
- •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
- •New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled hypertension (systolic/diastolic blood pressure >140/90mmHg), or other clinically significant cardiovascular abnormalities in the opinion of the investigator
- •Uncontrolled cardiac arrhythmia
- •Acute coronary syndrome (unstable angina pectoris or myocardial infarction) within the past 6 months
- •Major electrocardiogram (ECG) abnormalities in the opinion of the investigator
- •Severe infection or severe traumatism
- •Pneumonia or respiratory symptoms, such as dyspnea, cough, and fever, requiring treatment and other conditions likely to be accompanied by hypoxemia
- •History of drug or alcohol abuse within the past 3 months
- •Symptomatic or uncontrolled central nervous system (CNS) metastasis
- •Less than 4 weeks have elapsed since a major surgery and 2 weeks have elapsed since a minor surgery
- •Radiotherapy, hormone therapy, or chemotherapy within 2 weeks prior to baseline from which toxicities not recovered to ≤grade 1
- •>4 weeks of persistent Grade 3 (NCI-CTCAE v4.03) hematologic toxicities from prior anticancer treatment
- •History of myelodysplastic syndrome (MDS) or pre-treatment cytogenetic test results indicative of the risk of MDS or acute myelocytic leukemia
- •Ongoing or anticipated treatment with antiplatelet drugs (aspirin, clopidogrel, etc.) or anticoagulant drugs (warfarin, heparin, etc.) during the study
- •Requiring continuous treatment with systemic NSAIDs or systemic corticosteroids
- •Ongoing or past treatment with immunosuppressants within 14 days prior to the first dose of study treatment, except for intranasal, inhaled, topical, or locally injected (e.g., intraarticular injection) steroids
- •History of serious gastrointestinal bleedings within 12 weeks prior to screening or presence of diseases that may affect oral drug absorption (e.g., malabsorption syndrome, active peptic ulcer)
- •History of human immunodeficiency virus infection or active hepatitis B or C infection or ongoing uncontrolled chronic infectious disease
- •Pregnant or lactating women or patients planning to become pregnant during the study
- •Participation in another clinical trial within 30 days prior to screening
- •Individual considered ineligible for this study for other reasons, in the opinion of the investigator
研究组 & 干预措施
NOV140101 (IDX-1197)
Experimental
干预措施: NOV140101 (IDX-1197) (Drug)
结局指标
主要结局
Dose Limiting Toxicities (DLTs)
时间窗: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-21)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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