NCT04275583Unknown1 期
A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB3602 Capsule
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
This is a study to evaluate the tolerance, dose-limiting toxicity (DLT), phase II recommended dose (RP2D), and maximum tolerated dose (MTD) of single and multiple oral doses of TQB3474 in patients with advanced malignant tumors.
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
- •1.Understood and signed an informed consent form. 2.18 and 75 years old , male or female.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to
- •Life expectancy ≥12 weeks.
- •Relapsed/refractory multiple myeloma had received at least two treatment methods.
- •Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
排除标准
- •Hypersensitivity to TQB3602 or its excipient.
- •Has peripheral nerve diseases ≥ grade
- •Has diarrhea grade > 1 during screening period.
- •Has received chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other systemic antitumor therapies within 14 days before the first dose.
- •Has received ixazomib and less than 5 half-life before the first dose.
- •Has received allogeneic stem cell transplant.
- •Pregnant or lactating women.
- •Has participated in other clinical trials within 4 weeks before participating in this trial.
- •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
TQB3602 capsule
Experimental
TQB3602 capsule administered orally on day 1, 8, 15 in 28-day cycle.
干预措施: TQB3602 (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Baseline up to 28 days
Subjects appear the following toxic reaction relate to the drug after treatment within 28 days ：III °or above of non-hematological toxicity, IV° hematological toxicity , III ° neutropenia associated with fever, III ° thrombocytopenia with bleeding.
次要结局
- Cmax(0hour, 15minutes, 0.5hour, 1hour, 1.5hour, 2hour, 4hour, 8hour, 12hour, 24hour, 48hour, 96hour, 120hour, 144hour after oral administration of day 1 and day 15; Hour 0 of day 8 , hour 0 of day 29.)
- AUC0-t(0hour, 15minutes, 0.5hour, 1hour, 1.5hour, 2hour, 4hour, 8hour, 12hour, 24hour, 48hour, 96hour, 120hour, 144hour after oral administration of day 1 and day 15; Hour 0 of day 8 , hour 0 of day 29.)
- Tmax(0hour, 15minutes, 0.5hour, 1hour, 1.5hour, 2hour, 4hour, 8hour, 12hour, 24hour, 48hour, 96hour, 120hour, 144hour after oral administration of day 1 and day 15; Hour 0 of day 8 , hour 0 of day 29.)
研究者
研究点 (1)
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