NCT06165809撤回1 期
A Phase I Study to Evaluate the Safety and Tolerance of TQB3015 Tablets With Advanced Malignant Cancer.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
This study is divided into two stages: dose escalation and dose extension, including a single dose and a multiple dose clinical study. This is a single-center, open, non randomized, single arm study to the safety and tolerability of TQB3015 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;
- •Advanced malignant tumors confirmed by tissue or cellular pathology and the routine standard treatment was ineffective or lack of effective treatment plans, or patients cannot tolerate the standard treatment;
- •Has at least one assessable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria;
- •The main organs function well;
- •Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures during the study period and until at least 6 months after the last dose of study drug.
排除标准
- •Concomitant disease and medical history:
- •There were other malignant tumors occured within 3 years before the first dose of study drug.
- •Has multiple factors affecting oral medication;
- •Unalleviated toxicity ≥ grade 1 according to 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 before the first dose, 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, immunodeficiency;
- •Tumor-related symptoms and treatment:
- •Has known symptomatic central nervous system metastases and/or cancerous meningitis;
- •Have received surgery, chemotherapy, radiation therapy (2 weeks for brain radiation therapy) or other anti-cancer therapies within 4 weeks prior to the first dose.
- •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
TQB3015 tablets
Experimental
TQB3015 tables is administered as a single dose or multiple dose, 2-40mg once a day; Oral administration on fast condition, 21 days as a cycle.
干预措施: TQB3015 tablets (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: At the end of Cycle 1 (Day 21).
DLT will be defined as toxicities that meet pre-defined severity criteria according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity, and assessed as having a suspected relationship to study drug that occurred from the first dose to the end of the first treatment cycle.
Incidence of abnormal clinical laboratory
时间窗: 30 days after the last administration.
Incidence of participants with clinical laboratory abnormalities
Maximum tolerated dose (MTD)
时间窗: At the end of Cycle 1 (Day 21).
MTD was 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 TQB3015 tablets in adult patients with Advanced Malignant Cancer.
次要结局
- Serious adverse events (SAE)(30 days after the last administration.)
- Area under the concentration-time curve from zero to infinity (AUC0-∞)(Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days.)
- Apparent clearance (CL/F)(Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days.)
- Apparent volume of distribution (Vd/F)(Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days.)
- Adverse events (AE)(30 days after the last administration.)
- Half-life (t1/2)(Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days.)
- Area under the concentration-time curve from zero to last observation (AUC [0-t])(Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days.)
- Peak concentration (Cmax)(Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. Each cycle is 21 days.)
- Time to reach maximum (peak) plasma concentration (Tmax)(Pre-dose, at 0.5, 1, 2, 3,4, 6, 8, 11, 24, 48, 72 hours after single administration dose. Pre-dose on Cycle 1 Day 7,Cycle 1 Day 14, Cycle 1 Day21; 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours after-dose on Cycle 1 Day 21. 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 (1)
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