NCT05068856终止1 期
A Phase I, Multi-Center, Open Label, Dose Escalation/Expansion Study of HRS2543 in Patients With Advanced Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Dose-Limiting Toxicity (DLT)
研究概览
简要总结
To assess the safety and tolerability of HRS2543 in patients with advanced tumors and to determine the recommended phase II dose (RP2D) of HRS2543
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
- •18-70 years of age, both male and female
- •non standard treatment, invalid the standard treatment or refuse to receive standard treatment in patients with advanced tumors diagnosed by pathology
- •the Eastern Cooperative Oncology Group （ECOG） General status (performance status, PS) of 0-1
- •the expected lifetime ≥ 3 months
- •Has at least one measurable lesion as defined by RECIST v1.1
- •Written informed consent is provided by signing the informed consent form
排除标准
- •Any previous anti-tumor treatment
- •The toxicity caused by any previous anti-tumor treatment has not recovered to ≤ grade 1
- •Any other anti-tumor treatment is planned during the study treatment
- •After imaging diagnosis, there were brain tumor lesions
- •According to the judgment of the researcher, there are factors that can not swallow, chronic diarrhea and intestinal obstruction or other factors that can significantly affect the absorption, distribution, metabolism or excretion of drugs
- •Active heart disease was present within 6 months before the first administration of the study
- •Other malignancies occurred within 5 years before the first administration of the study
- •Active HBV or HCV infection
- •The subject had a history of immune deficiency
- •According to the judgment of the researcher, there are concomitant diseases that seriously endanger the safety of the subjects, confuse the analysis of the test results, or affect the subjects to complete the study
研究组 & 干预措施
HRS2543
Experimental
干预措施: HRS2543 (Drug)
结局指标
主要结局
Dose-Limiting Toxicity (DLT)
时间窗: Day 1 to 28 (Cycle 1)
A DLT is considered at AE related to study drug unless there is a clear, well-documented, alternative explanation for the toxicity. Severity of AEs are graded according to the NCI CTCAE 5.0 for the study, the occurrence of the following drug related AEs during the single dose and the first cycle (28 days) will be considered a DLT by the investigator and SMC.
Maximum Tolerated Dose (MTD)
时间窗: Day 1 to 28 (Cycle 1)
Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
Recommended PhaseII Dose (RP2D)
时间窗: Day 1 to 28 (Cycle 1)
Toxicity will be evaluated according to the NCI CTCAE Version 5.0.
次要结局
- Number of patients with changes in laboratory measurements(up to 24 months)
- Cmax of HRS2543 after single dose of HRS2543(Day 1 of Cycle 1(each cycle 28 days))
- Vz/F of HRS2543 after single dose of HRS2543(Day 1 of Cycle 1(each cycle 28 days))
- Tmax,ss of HRS2543 after multiple dose administration of HRS2543(Up to 4 cycles (each cycle 28 days))
- Number of patients with changes in single and triplicate 12-lead Electrocardiogram (ECG).(up to 24 months)
- Number of patients with changes in ECOG PS score.(up to 24 months)
- Number of patients with changes in Physical Examination.(up to 24 months)
- Number of patients with changes in Vital Signs(up to 24 months)
- Cmin,ss of HRS2543 after multiple dose administration of HRS2543(Up to 4 cycles (each cycle 28 days))
- Rac of HRS2543 after multiple dose administration of HRS2543(Up to 4 cycles (each cycle 28 days))
- DoR: the Duration of Response(up to 24 months)
- AUC0-∞ of HRS2543 after single dose of HRS2543(Day 1 of Cycle 1(each cycle 28 days))
- t1/2 of HRS2543 after single dose of HRS2543(Day 1 of Cycle 1(each cycle 28 days))
- AUCss of HRS2543 after multiple dose administration of HRS2543(Up to 4 cycles (each cycle 28 days))
- ORR: the Objective Response Rate(up to 24 months)
- DCR: the Disease Control Rate(up to 24 months)
- Incidence of adverse events (AEs).(up to 24 months)
- Tmax of HRS2543 after single dose of HRS2543(Day 1 of Cycle 1(each cycle 28 days))
- AUC0-t of HRS2543 after single dose of HRS2543(Day 1 of Cycle 1(each cycle 28 days))
- CL/F of HRS2543 after single dose of HRS2543(Day 1 of Cycle 1(each cycle 28 days))
- Cmax,ss of HRS2543 after multiple dose administration of HRS2543(Up to 4 cycles (each cycle 28 days))
- PFS: the Progression Free Survival(up to 24 months)
研究者
研究点 (1)
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