NCT04275050Unknown1 期
A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB3303 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
- Dose-limiting toxicity (DLT)
研究概览
简要总结
TQB3303 tablet is a small molecule oral drug inhibiting cyclin-dependent kinases 4 and 6 (CDK4 / 6). Based on current research, overexpression of positive regulatory proteins in the cell cycle is one of the important reasons for resistance to endocrine therapy. CDK4 / 6 is the key regulators of the cell cycle inhibiting tumor cell proliferation.
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
- •1.≥ 18 years old.
- •Histologically or cytologically confirmed advanced malignant solid tumors, without conventional treatment methods or fail or relapse after treatment.
- •3.Has at least one measurable lesion (based on RECIST 1.1) or bone metastases.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥12 weeks.
- •Adequate organ system function. 6.Understood and signed an informed consent form.
- •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
- •Has diagnosed and/or treated additional malignancy with the exception of cured basal cell carcinoma of the skin and cervical carcinoma in situ.
- •Has received cytotoxic chemotherapy in 4 weeks, or mitomycin C or nitrosourea in 6 weeks.
- •Has received any anti-tumor treatment such as hormone therapy, radioimmunotherapy, molecular targeted therapy, immunotherapy or other biological therapy within 4 weeks.
- •Has received other CDK4 / 6 inhibitors.
- •Has known spinal cord compression, cancerous meningitis, newly diagnosed central nervous system metastasis or brain metastases with stable symptoms less than 4 weeks; asymptomatic and stable imaging without corticosteroid treatment.
- •6.Has received stem cell or bone marrow transplant. 7.Has multiple factors affecting oral medication. 8.Has uncured wounds or fracture, except of pathological fracture with bone metastases patients.
- •9.Has uncontrolled cardiovascular disease. 10.Has received CYP3A4 inhibitors or inducers during the screening period and during the trial.
- •11.Has drug abuse history that unable to abstain from or mental disorders. 12.urinary protein ≥ ++, and the 24-hour urine protein quantification > 1.0 g.
- •Has active hepatitis B or C.
- •Has a history of autoimmune disease, immunodeficiency.
- •Hypersensitivity to TQB3303 or its excipient.
- •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
TQB3303 Tablet
Experimental
TQB3303 Tablet administered orally once. Then TQB3303 Tablet administered orally, once daily in 28-day cycle after 7 days of first administration.
干预措施: TQB3303 (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， III ° QTc interval extended
次要结局
- Overall response rate (ORR)(up to 96 weeks)
- AUC0-t(Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24, 48, 72, 120 hours post-dose on single dose; Hour 0 of day 7, day 14, day21 on multiple dose and hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24, 48, 72, 120 hours post-dose on multiple dose of day 28.)
- Cmax(Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24, 48, 72, 120 hours post-dose on single dose; Hour 0 of day 7,day 14,day21 on multiple dose and hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24, 48, 72, 120 hours post-dose on multiple dose of day 28.)
- Tmax(Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24, 48, 72, 120 hours post-dose on single dose; Hour 0 of day 7,day 14,day21 on multiple dose and hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24, 48, 72, 120 hours post-dose on multiple dose of day 28.)
- Duration of response (DOR)(up to 96 weeks)
- Progression-free survival (PFS)(up to 96 weeks)
- Disease control rate（DCR）(up to 96 weeks)
研究者
研究点 (1)
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