A Multicenter, Open Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of LIT-00814 Tablets in Patients With Advanced Solid Tumor/Esophageal Cancer.
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This study is a multi-center, open, dose-increasing and dose-expanding phase I clinical study, aiming at evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor activity of LIT-00814 tablets with different doses in China, and preliminarily evaluating the relationship between biomarkers and anti-tumor activity of LIT-00814 tablets.
This study includes two parts: Ia phase (i.e. dose escalation) and Ib phase (i.e. dose expansion).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •The subject or legal representative shall voluntarily sign the informed consent approved by the Ethics Committee before starting any screening procedure.
- •Male or female, age ≥18 years old.
- •Unresectable locally advanced or metastatic solid tumor confirmed by histology or cytology.
- •Subjects with relapsed and/or metastatic advanced solid tumors who have failed or have no standard treatment at present, or who are unable to accept standard treatment.
- •At least one target lesion.
- •ECOG score 0~
- •Subjects must have sufficient organ function.
- •Agree to use effective contraceptive measures within 3 months (about 90 days) from the signing of informed consent to the last administration of the study drug.
排除标准
- •The toxicity caused by previous treatment did not recover to ≤1 grade before the first study administration;
- •Known or symptomatic active central nervous system (CNS) metastasis or cancerous meningitis in the screening period;
- •Patients who have undergone surgery within 28 days before the first administration and have not recovered yet;
- •Suffering from uncontrolled or clinically significant cardiovascular diseases;
- •Other malignant tumors occurred within 3 years before the first administration;
- •Patients with active chronic hepatitis B, or patients with active hepatitis C, or patients with human immunodeficiency virus (HIV-Ab positive) or syphilis infection;
- •There are circumstances that affect the subjects' compliance with the research plan;
- •Other circumstances that the researcher thinks are not suitable for participating in this clinical study.
研究组 & 干预措施
LIT-00814 20mg
Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously.
干预措施: LIT-00814 (Drug)
LIT-00814 50mg
Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously.
干预措施: LIT-00814 (Drug)
LIT-00814 100mg
Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously.
干预措施: LIT-00814 (Drug)
LIT-00814 150mg
Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously.
干预措施: LIT-00814 (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 28 days post last drug administration
Determination of the MTD and RP2D of LIT-00814 monotherapy
时间窗: 24 days after the first dose
Defined as the highest dose level at which no more than 1 of 6 subjects experience a DLT during the DLT assessment window（24days）
次要结局
- Pharmacokinetic parameters：Area under the concentration-time curve (AUC)(C0D1-D3 0-72h（single dose），C1D1 0h、C1D8 0h、C2D1 0-8h（21days/cycle）)
- Overall survival (OS)(date of death from any cause or withdrawal of informed consent)
- Disease control rate (DCR)(Until documented the disease progresses or informed consent is withdrawn)
- Objective remission rate (ORR)(Until documented the disease progresses or informed consent is withdrawn)
- Treatment onset time (TTR)(Until documented the disease progresses or informed consent is withdrawn)
- Pharmacokinetic parameters：Maximum observed concentration（Cmax）(C0D1-D3 0-72h（single dose），C1D1 0h、C1D8 0h、C2D1 0-8h（21days/cycle）)
- Disease progression-free survival (PFS)(Until documented the disease progresses or informed consent is withdrawn)
- Pharmacokinetic parameters：Half-life (t1/2)(C0D1-D3 0-72h（single dose），C1D1 0h、C1D8 0h、C2D1 0-8h（21days/cycle）)