NCT04412577Unknown1 期
A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3473 Tablets
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
This is a study to evaluate the maximum tolerated dose (MTD), occurrence of all adverse events (AE) and serious adverse events (SAE) , pharmacokinetic parameters and antitumor effect of TQB3473 tablets in Chinese adult patients with Relapsed or refractory hematological malignancies.
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.
- •Relapsed or refractory malignant hematological tumors.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.
- •Has at least one measurable lesion.
- •Adequate organ system function.
- •Patients need to adopt effective methods of contraception.
排除标准
- •Severe hypersensitivity to the drug or ingredients.
- •Has received chemotherapy, radiotherapy, immunotherapy or any other anti-tumor therapy within 14 days before the first dose.
- •Has received spleen tyrosine kinase (SYK) inhibitors.
- •Has to use ≥ 10 mg/day glucocorticoid prednisone.
- •Has received BTK inhibitors and PI3K inhibitors before the first dose.
- •Has received allogeneic hematopoietic stem cell transplantation.
- •Has received autologous hematopoietic stem cell transplantation within 12 weeks before the first dose.
- •Has any acute or chronic gastrointestinal diseases.
- •Has primary central nervous system lymphoma, or brain metastases with clinical symptoms, spinal cord compression, cancerous meningitis.
- •Intermediate-risk or high-risk myelodysplastic syndrome.
- •Pregnancy and lactation women.
- •Has any serious and/or uncontrollable disease.
- •Has active autoimmune disease and received immunosuppressive therapy.
- •Has a history of neurological or mental disorders.
- •Has uncontrollable systemic bacterial, fungal or viral active infections
- •The toxicity of previous antitumor treatment is not recovered to ≤ grade
- •Has other malignancies.
- •Has received surgery within 4 weeks before the first administration.
- •Has participated in any other clinical trials.
- •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
TQB3473 tablets
Experimental
TQB3473 tablets administered once daily in 28-day cycle .
干预措施: TQB3473 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: up to 31 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, 1hour, 2hour, 4hour, 6hour, 8hour,12hour, 24hour, 48hour post-dose on day 1 and day 31; 30minutes pre-dose on day 1, day 4, day 11,day 18 ,day 25 and day 31.)
- Cmax Cmax(30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,12hour, 24hour, 48hour post-dose on day 1 and day 31; 30minutes pre-dose on day 1, day 4, day 11,day 18 ,day 25 and day 31.)
- AUC0-t(30minutes, 1hour, 2hour, 4hour, 6hour, 8hour,12hour, 24hour, 48hour post-dose on day 1 and day 31; 30minutes pre-dose on day 1, day 4, day 11,day 18 ,day 25 and day 31.)
- Overall response rate (ORR)(up to 96 weeks)
- Progression-free survival (PFS)(up to 96 weeks)
- Duration of Response (DOR)(up to 96 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
1 期
A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3558 TabletsAdvanced Solid TumorsNCT04408079Chia Tai Tianqing Pharmaceutical Group Co., Ltd.70
已完成
1 期
A Study to Evaluate the Safety and Pharmacokinetics of CDX-0158 in Adult Patients With Advanced Solid TumorsAdvanced CancerNCT02642016Celldex Therapeutics28
终止
1 期
M8891 First in Human in Solid TumorsAdvanced Solid TumorsMetastatic Renal Cell CarcinomaNCT03138538EMD Serono Research & Development Institute, Inc.27
终止
1 期
Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML)Leukemia, Myeloid, AcuteNCT02003573Boehringer Ingelheim13
终止
1 期
Dose Escalation of IPI-493 in Hematologic MalignanciesHematologic MalignanciesNCT01193491Infinity Pharmaceuticals, Inc.4