NCT06344351已完成1 期
A Phase I Study to Evaluate the Safety, Tolerance and Pharmacokinetics of TQB3006 Tablets in Patients With Advanced Malignant Cancer
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
- 27
- 试验地点
- 5
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
This study includes two stage: dose escalation and dose extension, with a single dose and a multiple dose study. This is a single-center, open, non-randomized, single arm, study to evaluate the safety, tolerability and pharmacokinetics of TQB3006 tables in patients with advanced malignant cancer.
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
- •Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
- •Age: 18 to 75 years old; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Has at least one assessable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1;
- •Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures during the study period to at least 6 months after the last dose of study drug.
排除标准
- •There were other malignant tumors within 3 years;
- •Has multiple factors affecting oral medication;
- •Unalleviated toxicity ≥ grade 1 of CTCAE v5.0 due to any previous therapy , excluding hair loss;
- •Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study，or have not fully recovered from previous surgery, or are expected to require major surgical surgery during the study period;
- •Arteriovenous thrombotic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;
- •Have a history of psychotropic drug abuse and can not quit or have mental disorders;
- •Subjects with any severe and / or uncontrolled disease including active hepatitis, a history of immunodeficiency, etc.;
- •Tumor-related symptoms and treatment:
- •Has known symptomatic central nervous system metastases and/or cancerous meningitis;
- •Thoracic/abdominal/pericardial effusion with clinical symptoms or requiring repeated drainage, or drainage for the purpose of receiving treatment within 1 month after receiving the investigational drug for the first time;
- •Has participated in other clinical trials within 4 weeks before first dose.
- •According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
研究组 & 干预措施
TQB3006 tablets
Experimental
TQB3006 tables is administered as a single dose or multiple dose .Take200-1200 mg per day; Take TQB3006 orally on an empty stomach once or twice a day, 21 days as a cycle.
干预措施: TQB3006 tablets (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: At the end of Cycle 1 (21 Days).
DLT will be defined as toxicities that meet pre-defined severity criteria (according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version5.0), and assessed as having a suspected relationship to study drug that occurred from first medication to the end of the first treatment cycle.
Recommended phase II dose (RP2D)
时间窗: Baseline up to 24 months.
DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3006 tablets in adult patients with Advanced Malignant Cancer
Maximum tolerated dose (MTD)
时间窗: At the end of Cycle 1 (21 Days).
MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
次要结局
- Adverse events (AE)(30 days after the last dose.)
- Serious adverse events (SAE)(30 days after the last dose.)
- Time to reach maximum plasma concentration (Tmax)(Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.)
- Peak concentration (Cmax)(Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.)
- Area under the concentration-time curve (AUC [0-infinity])(Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.)
- Half-life (t1/2)(Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.)
- Area under the concentration-time curve (AUC [0-t])(Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.)
- Apparent clearance (CL/F)(Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.)
- Apparent volume of distribution (Vd/F)(Day 1: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hours after-dose. Cycle 1 Day 1,Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day 21: pre-dose, Cycle 1 Day 21: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose. Each cycle is 21 days.)
- Objective response rate (ORR)(From date of the first dose until the date of first documented progression or date of death from any cause, assessed up to 100 weeks)
研究者
研究点 (5)
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