NCT05046847Unknown1 期
Phase I Clinical Study to Evaluate the Tolerability and Pharmacokinetics of TQB3811 Tablets in Patients With Advanced Malignant Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
TQB3811 tablet is a second-generation tropomyosin receptor kinase (TRK) inhibitor that selectively inhibits the kinase activity of TRKA, TRKB, and TRKC, and also selectively inhibits the kinase activity of TRKA, TRKB, and TRKC that produce secondary drug-resistant mutations.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced malignancy diagnosed histologically and/or cytologically, who have failed standard treatment or are unable to receive standard treatment or have no effective treatment.
- •Age: 18~75 years old.
- •Women of childbearing age must be negative for serum or urine HCG within 7 days prior to study enrollment and must be non-lactating; Patients should agree to use contraception during the study period and for 6 months after the study period.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- •Patients voluntarily joined the study and signed the informed consent, showing good compliance.
排除标准
- •Patients has had or is currently having other malignant tumors within 3 years.
- •Patients have multiple factors that affect their oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction).
- •The patient had unmitigated toxic reactions due to any prior treatment.
- •Patients underwent major surgical treatment, open biopsy, or significant traumatic injury within 4 weeks prior to the start of study treatment.
- •Patients have long-term unhealed wounds or fractures.
- •The patient had experienced an arterial/venous thrombosis event in the past 6 months, such as a cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis, and pulmonary embolism.
- •The patient has a history of psychotropic drug abuse and cannot quit or has mental disorders.
- •Patients are taking cytochrome P450 3A (CYP3A) inhibitors or inducers.
- •Patients have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.
- •Patients with brain metastases with symptoms or control of symptoms for less than 2 weeks.
- •The patients were currently breastfeeding or planned to breastfeed during the study period.
- •Patients who, in the investigator's judgment, have a comorbidity that seriously endangers patient safety or interferes with study completion, or who are considered unsuitable for inclusion for other reasons
研究组 & 干预措施
TQB3811
Experimental
The initial dose is 2.5mg, once a day (QD), and the medication stage is divided into single administration and continuous administration. The single administration is given once a day, and the continuous administration is entered 4 days after drug withdrawal. The drug is administered continuously until the disease progresses.
干预措施: TQB3811 (Drug)
结局指标
主要结局
Adverse events (AEs) and serious adverse events (SAEs)
时间窗: Baseline up to 28 days
The occurrence of all AEs and SAEs
Dose-limiting toxicity (DLT)
时间窗: Baseline up to 32 weeks
To evaluate DLT of TQB3811 tablets in Chinese adult patients with advanced solid tumors
Maximum tolerated dose (MTD)
时间窗: Baseline up to 32 weeks
To evaluate MTD of TQB3811 tablets in Chinese adult patients with advanced solid tumors
次要结局
- Time to reach maximum (peak) plasma concentration following drug administration（Tmax）(15, 30minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.)
- Concentration at the end of the dosing interval (AUCtau,ss)(15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.)
- Disease control rate（DCR）(up to 96 weeks)
- Duration of Response (DOR)(up to 96 weeks)
- Maximum (peak) plasma drug concentration （Cmax）(15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 ;30 minutes before oral administration on day 1.)
- Elimination half-life （t1/2）(15, 30minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.)
- Area under the plasma concentration-time curve from time zero to time t （AUC0-t）(15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 ;30 minutes before oral administration on day 1.)
- Maximum (peak) steady-state plasma drug concentration during a dosage interval （Cmax,ss）(15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.)
- Minimum steady-state plasma drug concentration during a dosage interval （Css-min）(15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11.)
- Progress Free Survival（PFS）(up to 96 weeks)
研究者
研究点 (1)
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