NCT04523285Unknown1 期
A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, and Pharmacokinetics of TQB3728 Tablets
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
This is a open-label, phase I study to evaluate tolerance and pharmacokinetics of TQB3728 tablets in subjects with advanced solid tumor or hematologic tumor.
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.Histologically or cytologically confirmed advanced/metastatic or refractory solid tumor or lymphoma. No approved standard treatment regimen or ineffective or intolerant to standard treatment regimen.
- •3.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥12 weeks.
- •Has at least one measurable lesion (solid tumors based on RECIST V1.1, lymphoma based on Lugano 2014).
- •5.Adequate organ system function. 6.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 first administration.
排除标准
- •1.Hypersensitivity to TQB3728 or its excipient. 2.Has received chemotherapy, radiotherapy, hormone therapy, immunotherapy, targeted therapy, biotherapy or any other antitumor therapy within 4 weeks before first administration.
- •3.Has received allogeneic hematopoietic stem cell transplantation or organ transplantation, or received autologous hematopoietic stem cell transplantation within 12 weeks before administration.
- •4.Has multiple factors affecting oral medication. 5.Has primary CNS lymphoma or CNS metastasis with untreated or uncontrolled symptoms.
- •6.Pregnant or lactating women. 7.Has severe or uncontrolled systemic disease. 8.Has serious cardiovascular diseases. 9.Has neurological or mental disorders. 10.Has autoimmune disease or diseases requiring systemic hormones or immunosuppressive drugs.
- •11.Has active viral infection. 12.The related toxicity of previous anti-tumor therapy has not recovered to CTCAE ≤ grade 1, except for hair loss.
- •Has received major surgery within 4 weeks before the first administration. 14.Has participated in other clinical trials within 4 weeks before participating in this trial.
- •15.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
TQB3728 tablets
Experimental
TQB3728 tablets administered orally, once a week in 28-day cycle.
干预措施: TQB3728 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: Baseline up to 28 days
MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
次要结局
- Tmax(30minutes pre-dose on day 1and day 8;1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 24hour, 72hour post-dose on day 1 and day 8; 48hour, 96hour post-dose on day 1.)
- Cmax(30minutes pre-dose on day 1and day 8;1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 24hour, 72hour post-dose on day 1 and day 8; 48hour, 96hour post-dose on day 1.)
- AUC0-t(30minutes pre-dose on day 1and day 8; 1hour, 2hour, 3hour, 4hour, 6hour, 8hour, 24hour, 72hour post-dose on day 1 and day 8; 48hour, 96hour post-dose on day 1.)
- Progression-free survival (PFS)(up to 48 weeks)
- Overall response rate (ORR)(up to 48 weeks)
研究者
研究点 (1)
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