NCT04340427Unknown1 期
A Phase I Study of TQB3455 Tablets in Subjects With Advanced Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
This is a open-label, multicenter, phase I study to evaluate tolerance and pharmacokinetics of TQB3455 tablets in subjects with advanced 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old； Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥12 weeks.
- •Has IDH2 gene mutation will be selected preferentially.
- •The toxicity of radiotherapy or other antitumor therapy should return to grade
- •No pregnant or lactating women, all the participants should use contraceptives.
- •Understood and signed an informed consent form.
- •Advanced/metastatic solid tumors or refractory/recurrent acute myeloid leukemia.
- •At least one measurable lesion for solid tumors.
- •Adequate organ system function.
排除标准
- •1.Relapsed after bone marrow transplantation. 2.Has received systemic antitumor therapy or radiation therapy within 3 weeks before the first dose.
- •3.Has participated in other clinical trial within four weeks before the first dose.
- •4.Has multiple factors affecting oral medication. 5.Has uncontrolled, active systemic fungal, bacterial, or viral infections. 6.Poorly controlled hypertension. 7.Has serious cardiovascular disease. 8.Has drug abuse history that unable to abstain from or mental disorders. 9.Has active hepatitis B or C. 10.Have a history of immunodeficiency. 11.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
- •12.Has central nervous system metastasis with the exception of glioma subjects. 13.Has severe life-threatening complication of leukemia, such as uncontrolled bleeding, hypoxia or shock pneumonia, and disseminated intravascular coagulation.
- •14.Has central nervous system leukemia.
研究组 & 干预措施
TQB3455 Tablets
Experimental
TQB3455 Tablet administered orally once. Then TQB3455 Tablet administered orally, once daily in 28-day cycle after 7 days of first administration.
干预措施: TQB3455 (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Baseline up to 28 days
Subjects appear the toxic reaction relate to the drug after treatment within 28 days.
次要结局
- Tmax(Hour 0, 1, 2, 3, 5, 8, 10, 12, 24, 48, 72, 96, 120, 144 hours post-dose on single dose; Hour 0 of day 8,day 15,day22 on multiple dose and hour 0, 1, 2, 3, 5, 8, 10, 12, 24 hours post-dose on multiple dose of day 28.)
- Cmax(Hour 0, 1, 2, 3, 5, 8, 10, 12, 24, 48, 72, 96, 120, 144 hours post-dose on single dose; Hour 0 of day 8, day 15, day22 on multiple dose and hour 0, 1, 2, 3, 5, 8, 10, 12, 24 hours post-dose on multiple dose of day 28.)
- AUC0-t(Hour 0, 1, 2, 3, 5, 8, 10, 12, 24, 48, 72, 96, 120, 144 hours post-dose on single dose; Hour 0 of day 8,day 15,day22 on multiple dose and hour 0, 1, 2, 3, 5, 8, 10, 12, 24 hours post-dose on multiple dose of day 28.)
- α-Hydroxyglutaric acid (2-HG)(Day 1, Day 8 and Day 15 pre-dose on cycle 1; Day1, Day15 pre-dose on cycle 2 and cycle 3; Day 1 pre-dose on multiple dose from cycle 4 to cycle 8. Each cycle is 28 days.)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Clinical Trial of TQB3455 Tablets in Patients With Hematological MalignanciesAcute Myeloid Leukemia (AML)Myelodysplastic Syndrome (MDS)NCT06550713Chia Tai Tianqing Pharmaceutical Group Co., Ltd.100
Unknown
1 期
A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 TabletsAdvanced Solid Tumor or Hematologic TumorNCT04481607Chia Tai Tianqing Pharmaceutical Group Co., Ltd.96
尚未招募
1 期
A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of TQ-B3234 in Patients With Type I NeurofibromatosisType I NeurofibromatosisNCT05107037Chia Tai Tianqing Pharmaceutical Group Co., Ltd.120
Unknown
1 期
A Phase I Study of TQB728 Tablets on Tolerance and PharmacokineticsAdvanced Solid Tumor or Hematologic TumorNCT04523285Chia Tai Tianqing Pharmaceutical Group Co., Ltd.40
Unknown
1 期
A Study of TQ-B3525 Tablets Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast CancerHR-positive, HER2-negative and PIK3CA Mutation Advanced Breast CancerNCT04355520Chia Tai Tianqing Pharmaceutical Group Co., Ltd.42