NCT04481607Unknown1 期
A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 Tablets
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 96
- 试验地点
- 5
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
This is a open-label, multicenter, phase I study to evaluate tolerance and pharmacokinetics of TQB3454 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
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.
- •Advanced solid tumors or hematological malignancy.
- •Adequate laboratory indicators.
- •No pregnant or breastfeeding women, and a negative pregnancy test.
- •Understood and Signed an informed consent form.
排除标准
- •Has central nervous system metastasis or system leukemia. 2.Previous anti-tumor treatment:
- •Has received IDH1 mutation inhibitor.
- •Has received systemic anti-tumor therapy or radiotherapy within 14 days before the first dose.
- •Has received oral targeted drugs, less than 5 drug half-lives from first dose.
- •The related toxicity of previous anti-tumor therapy has not recovered to CTCAE ≤ grade 2, except for hair loss.
- •3.Complicated disease and medical history:
- •Active hepatitis B or hepatitis C.
- •Abnormal kidney.
- •Abnormal cardiovascular and cerebrovascular.
- •Abnormal gastrointestinal.
- •Has medical history of immunodeficiency.
- •Has bleeding (hemoptysis), coagulopathy, or been using warfarin, aspirin, and other antiplatelet agglutination drugs.
- •Has uncontrollable systemic bacterial, fungal or viral active infections.
- •Has medical history of idiopathic pulmonary fibrosis,or tissue pneumonia.
- •Has allergic constitution or previous severe allergy; or known allergy to ingredients of study drug.
- •Has neurological or mental disorders.
- •Has a history of drug abuse or drug addict.
- •Has received major surgery, open biopsy, or obvious traumatic injury within 4 weeks before the first dose.
- •According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
- •Has participated in other clinical trials within 30 days before participating in this trial.
- •Female patients during pregnancy or lactation.
- •According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
- •criteria for solid tumors:
- •Has any signs of bleeding constitution.
- •Has any CTCAE ≥ grade 3 bleeding or bleeding event,within 4 weeks before the first dose.
- •Has unhealed wounds, fractures, active ulcers of the stomach and duodenum, ulcerative colitis and other digestive tract diseases.
- •Imaging (CT or MRI) shows that the tumor has invaded the circumference of important blood vessels.
- •Has uncontrollable pleural effusion, pericardial effusion or ascites that still need repeated drainage.
- •criteria for blood tumor:
- •a) Has severe life-threatening leukemia complications.
研究组 & 干预措施
TQB3454 tablets
Experimental
TQB3454 tablets administered orally once. Then TQB3454 tablets administered orally, once daily in 28-day cycle after 7 days of first administration.
干预措施: TQB3454 (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(Hour 0(pre-dose), 0.5, 1, 2, 3, 5, 8, 10, 24, 48, 72, 120, 168 hours post-dose on single dose;)
- Progression-free survival (PFS)(Up to 60 weeks)
- AUC0-t(Hour 0(pre-dose), 0.5, 1, 2, 3, 5, 8, 10, 24, 48, 72, 120, 168 hours post-dose on single dose;)
- Cmax(Hour 0(pre-dose), 0.5, 1, 2, 3, 5, 8, 10, 24, 48, 72, 120, 168 hours post-dose on single dose;)
- Objective response rate (ORR)(up to 60 weeks)
- 2-hydroxyglutaric acid(Hour 0(pre-dose) on single dose; Hour 0(pre-dose) of day1, day8, day15, day28 on multiple dose of first cycle; hour 0(pre-dose) of day15, day28 of second and third cycle; hour 0(pre-dose) of day28 of fourth to eighth cycle.Each cycle is 28 days.)
研究者
研究点 (5)
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