A Phase I Study to Evaluate the Safety and Tolerance of TQB3117 Tablets in Patients With Advanced Malignant Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
The study is divided into two phases: dose escalation and dose extension. The dosing regimens include a single-dose study and a multiple-dose study. It adopts a single-center, open-label, non-randomized, single-arm clinical trial design, where patients with advanced malignant cancer are selected to orally take TQB3117 tablets. The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of TQB3117 tablets in patients.
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 criteria;
- •The main organs function well;
- •Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.
排除标准
- •There were other malignant tumors in 3 years;
- •Has multiple factors affecting oral medication;
- •Unalleviated toxicity ≥ grade 1 above 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 included: active hepatitis, have a history of immunodeficiency;
- •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 one 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
TQB3117 tablets
TQB3117 tables is administered as a single dose or multiple dose, ranging from 20 to 180 mg once daily. Oral administration on fast condition, with each cycle lasting 21 days.
干预措施: TQB3117 tablets (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: At the end of Cycle 1 (each cycle is 21 days)
DLT refers to occurrence of drug-related adverse events within the first treatment cycle after subjects receive single-dose or multiple-dose treatment, as defined by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity assessment criteria.
Maximum tolerated dose (MTD)
时间窗: At the end of Cycle 1 (each cycle is 21 days)
MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
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 TQB3117 tablets in adult patients with advanced malignant cancer.
次要结局
- Adverse events (AE)(30 days after the last administration)
- Serious adverse events (SAE)(30 days after the last administration)
- Time to reach maximum plasma concentration (Tmax)(Day 1 of single dose: pre-dose, at 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7,14 and 21 of cycle1: pre-dose. Day 21of cycle1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.)
- Peak concentration (Cmax)(Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7,14 and 21 of cycle1: pre-dose. Day 21 of cycle 1: at 0.5,1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.)
- Half-life (t1/2)(Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.)
- Apparent clearance (CL/F)(Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.)
- Area under the concentration-time curve (AUC [0-infinity](Day 1 of single dose: pre-dose, at 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose, Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.)
- Area under the concentration-time curve (AUC [0-t](Day 1 of single dose: pre-dose, at 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.)
- Apparent volume of distribution (Vd/F)(Day 1 of single dose: pre-dose, at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours after-dose. Days 7, 14 and 21 of cycle 1: pre-dose. Day 21 of cycle 1: at 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours after-dose.)
- 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 100weeks)