NCT05144061已完成1 期
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) of HRS2398 in Subjects With Advanced Malignant 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
- 28
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity（DLT）
研究概览
简要总结
The study is being conducted to determine the dose limited toxicity(DLT) and maximum tolerated dose(MTD) and recommended Phase 2 dose(RP2D) of HRS2398 in subjects with advanced malignant tumor ; The second objectives is to evaluate safety and preliminary efficacy and PK profile of HRS2398 in subjects with advanced malignant tumor ; Exploratory cohort is to explore the relationship between gene mutation and efficacy and resistance mechanisms.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
- •subjects ≥18 years and ≤70 years.
- •Patients with Histologically or cytologically confirmed advanced Malignant tumors who had failed standard treatment or had not been treated with standard therapy.
- •Subjects with life expectancy of ≥ 3 months.
- •At least one measurable lesion ( RECIST version 1.1).
- •Subjects must have adequate organ function (whole blood or component transfusion or BFGF within 2 weeks before 1st dose of study drug is prohibited):
- •Absolute neutrophil count (ANC) ≥1.5 x10^9/L;
- •Platelet count ≥ 100 x 10^9/L;
- •Hemoglobin ≥ 90 g / L;
- •Total bilirubin (TBil) ≤1.5 x ULN;
- •Liver function tests alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x ULN, for patients with known liver cancer or liver metastases, AST and ALT ≤ 5 x ULN;
- •Gr ≤ 1.5x ULN or an estimated glomerular filtration rate (eGFR) > 50 mL/min;
- •INR ≤1.5 x ULN and APTT ≤ 1.5 x ULN;
- •LVEF≥50%，QTc Male: <450ms; Female: <470ms.
- •Subjects (males and females) of childbearing potential should be willing to use reliable contraception methods that are deemed effective by the investigator from visit 1 through 180 days following the last dose of study drug.
- •Archived wax lump tumor tissue samples or biopsy and blood sample collection during screening period.
- •As judged by the investigator, can follow protocol.
排除标准
- •Untreated and/or uncontrolled brain metastases.
- •Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 weeks prior to the first administration.
- •Failure to recover from adverse events from the most recent anti-tumor treatment to CTCAE ≤ grade
- •Inability to swallow tablets or gastrointestinal disease, possible impairment of adequate absorption of study drugs.
- •Have severe cardiac disease:NYHA class ≥grade II heart failure; unstable angina pectoris；myocardial infarction within 12 months； clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; Hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
- •Known active hepatitis C virus, or known active hepatitis B virus.
- •Allergic to the HRS2398 or the similar drug.
- •Concurrent anticancer treatment or use of other investigational product within 4 weeks before start of trial treatment; major surgery, radiotherapy, chemotherapy within 4 weeks before 1st dose of trial treatment.
- •The patient is currently using a drug known to be a strong inhibitor of CYP3A4 within 2 weeks before 1st dose of study drug ，or strong inducer of CYP3A4 within 4 weeks before 1st dose of study drug .
- •The investigator determined that the patient should not participate in the study.
研究组 & 干预措施
Single Arm
Experimental
HRS2398 Tablets
干预措施: HRS2398 Tablets (Drug)
结局指标
主要结局
Dose-limiting toxicity（DLT）
时间窗: up to 21 days
Maximum tolerated dose（MTD）
时间窗: up to 6 months
Recommended Phase II Dose (RP2D)
时间窗: up to 21 days
次要结局
- AUC0-t of HRS2398 of Single administration(ingle administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours, 24hours, 48hours, 72hours after administration of Day1)
- Number of subjects with adverse events and the severity of adverse events(from the first drug administration to within 30 days for the last treatment dose)
- Cmax of HRS2398 of Single administration(Single administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours, 24hours, 48hours, 72hours after administration of Day1)
- Tmax of HRS2398 of Single administration(Single administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours, 24hours, 48hours, 72hours after administration of Day1)
- AUC0-12 of HRS2398 of Single administration(Single administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours after administration of Day1)
- T1/2 of HRS2398 of Single administration(Single administration : 30min before administration of Day1, 5min, 0.25 hour, 0.5 hour, 0.75 hour, 1 hour , 2hours, 4hours, 6hours, 8hours, 10hours, 24hours, 48hours, 72hours after administration of Day1)
- Cmax of HRS2398 of Multiple doses(Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days))
- Tmax of HRS2398 of Multiple administration(Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days))
- AUC0-t of HRS2398 of Multiple administration(Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days))
- AUC0-12 of HRS2398 of Multiple administration(Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days))
- T1/2 of HRS2398 of Multiple administration(Multiple administration: Day8, Day15, Day17 of Cycle1, Day1 of Cycle2-4 (each cycle is 21 days))
- Bioavailability of fasting state(up to 4 months)
- Objective Response Rate(ORR)(up to 4 months)
- Disease Control Rate(DCR)(up to 4 months)
- Duration of response (DoR)(up to 4 months)
- Progression free survival(PFS)(up to 4 months)
研究者
研究点 (1)
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