A Phase I Study to Evaluate the Safety and Pharmacokinetics of TQB3824 in Subjects With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
TQB3824 blocks function of a specific protein called Cell Division Cycle 7 (CDC7) kinase in the human body, which plays important roles in the maintenance of DNA replication forks and DNA damage response pathways. This study will evaluate the safety, tolerability and pharmacokinetics of TQB3824.
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
- •Understood and signed an informed consent form;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
- •Life expectancy >=3 months;
- •Progressed after standard treatment or no standard treatment with an established survival benefit is available;
- •Adequate organ/system function;
- •Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.
排除标准
- •Diagnosed and/or treated additional malignancy within 3 years before the first dose;
- •With factors affecting oral medication;
- •Toxicity that is >=Grade 2 caused by previous cancer therapy;
- •Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before the first dose;
- •Arterial thromboembolism and/or venous thromboembolism within 6 months;
- •A history of psychotropic drug abuse or have a mental disorder;
- •Any severe and/or uncontrolled disease;
- •Has received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks before the first dose;
- •Has received Chinese patent medicines with anti-tumor indications that National Medical Products Administration (NMPA) approved within 2 weeks before the first dose;
- •Has received CDC7 inhibitors;
- •Pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage;
- •Brain metastases ;
- •Has participated in other clinical studies within 4 weeks before the first dose;
- •According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
研究组 & 干预措施
TQB3824 tablets
TQB3824 tablets orally administrated orally on Days 1-21 of each 21-day treatment cycle. Dose escalation of TQB3824 will be based on evaluation of clinical safety and tolerability and guided by accumulating PK data
干预措施: TQB3824 tablets (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: up to 18 months
DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Maximum Tolerated Dose (MTD)
时间窗: up to 18 months
The maximum Dose at which less than 33% subjects experiencing DLT
Recommended Phase II Dose (RP2D)
时间窗: up to 18 months
RP2D will be based on evaluation of clinical safety and tolerability and guided by accumulating PK data
次要结局
- Area under the plasma concentration-time curve (AUC)(up to 18 months)
- Maximum (peak) plasma drug concentration (Cmax)(up to 18 months)
- Time to reach maximum(peak )plasma concentration following drug administration (Tmax)(up to 18 months)
- Overall response rate (ORR)(Baseline up to 12 months)
- Disease Control Rate (DCR )(Baseline up to 12 months)
- Duration of Response (DOR)(Baseline up to 12 months)
- Progression-free survival (PFS)(Baseline up to 12 months)
- Overall survival (OS)(Baseline up to 12 months)