NCT05983146撤回1 期
A Phase I, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-7053 Injection in Patients With Advanced Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 186
- 主要终点
- Incidence and severity of adverse events (AES)
研究概览
简要总结
To evaluate the safety and tolerability of multiple administration of HRS-7053 in patients with advanced malignancies Determine the maximum tolerated dose (MTD, if possible) and the recommended dose for Phase II clinical studies (RP2D)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation in this study, signed informed consent, compliance is good, can cooperate with follow-up
- •Age ≥18 years, both male and female
- •Histologically or cytologically confirmed patients with advanced hematologic malignancies that have not responded to standard antitumor therapy and currently indicate treatment
- •Have measurable lesions
- •ECOG PS score: 0-1
- •Have a life expectancy of at least 3 months
- •The functional level of the major organs must meet the requirements
- •Fertile female patients must have a serum pregnancy test within 7 days before the first medication and the result is negative; And must be non-lactating
排除标准
- •The tumor infiltrates the central nervous system
- •Received autologous stem cell transplantation within 12 weeks prior to administration of the first study; Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation; In the first study, Car T cell therapy was administered within 12 weeks prior to drug administration
- •Had major surgery or severe trauma 4 weeks prior to the first study; Or plan to undergo major surgery during the study
- •Received antitumor therapy within 2 weeks prior to administration of the first study drug; Received Chinese herbal therapy within 2 weeks before the first dose of study drug administration; Receiving steroid hormones for antitumor purposes within 7 days before the first dose of the investigational drug administration
- •Use of live attenuated vaccine within 28 days prior to signing the informed consent, or expected to require live attenuated vaccine during the study period to 5 months after the final dose
- •Use of any potent drug that inhibits the liver drug metabolizing enzyme CYP3A for 14 days prior to first administration; Any potent drug that induces the liver drug metabolizing enzyme CYP3A has been used for 28 days prior to first administration
- •Previous treatment-induced adverse events did not recover to ≤CTCAE grade 1
- •Participating in other clinical studies or signing informed consent less than 1 month after the last medication in the previous clinical study
- •The active phase of HBV or HCV infection is known
- •A history of immunodeficiency, including HIV seropositive, or other acquired, congenital immunodeficiency disorders
- •Active infection or unexplained fever > 38.5 ° c
- •A history of clinically severe cardiovascular disease; A history of myocarditis within one year prior to drug administration was first studied
- •The abnormality of electrocardiogram (ECG) was clinically significant
- •In the first study, cerebrovascular accident, transient ischemic attack occurred within 6 months prior to drug administration
- •History of other malignancies within 5 years prior to drug administration was first studied
- •Known allergy to any component of the HRS-7053 product
- •The presence of other serious physical or mental illnesses, abnormal laboratory tests, and other factors that may increase the risk of participating in the study or interfere with the study results; And any other conditions that the investigator deems inappropriate for participation in this study
- •Female subjects are pregnant or breastfeeding
研究组 & 干预措施
HRS-7053 Injection
Experimental
干预措施: HRS-7053 Injection (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AES)
时间窗: up to 3 years
MTD
时间窗: up to 3 years
RP2D
时间窗: up to 3 years
次要结局
- Overall survival (OS)(up to 3 years)
- Time to maximum concentration (Tmax)(up to 3 years)
- Maximum concentration (Cmax)(up to 3 years)
- Disease control rate (DCR)(up to 3 years)
- Progression-free survival (PFS)(up to 3 years)
- Area under the time curve from 0 to the last measurable concentration time point t (AUC0-t)(up to 3 years)
- Objective response rate （ORR）(up to 3 years])
- Duration of response (DoR)(up to 3 years)
研究者
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