NCT04412564Unknown2 期
A Open-label, Single-arm Phase Ⅱ Clinical Trial of TQ-B3101 Capsules in Subjects With Advanced Malignant Tumor
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 36
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
The objective of this study is to evaluate efficacy and safety of TQ-B3101 in subjects with advanced malignant 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 —（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.
- •Understood and signed an informed consent form.
- •Histologically or cytologically confirmed advanced malignant solid tumors.
- •Adequate organ system function.
- •Patients need to adopt effective methods of contraception.
排除标准
- •Has multiple factors affecting oral medication.
- •The toxicity of previous antitumor treatment is not recovered to ≤ grade
- •Other malignancies occurred within 3 years, with exception of cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors.
- •Has a history of hypertension, hypertensive encephalopathy or uncontrolled hypertension.
- •Has cardiovascular and cerebrovascular diseases.
- •Has received radiotherapy, chemotherapy, surgery less than 4 weeks before the first dose.
- •Has central nervous system metastasis and / or spinal cord compression, cancerous meningitis, and meningeal disease.
- •Active hepatitis, HIV positive, syphilis positive.
- •Has a history of psychotropic substance abuse.
- •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
TQ-B3101 capsules
Experimental
TQ-B3101 capsules 300mg bid administered orally in 28-day cycle.
干预措施: TQ-B3101 (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: up to 48 weeks
Percentage of subjects achieving complete response (CR) and partial response (PR).
Adverse events (AE) and serious adverse events (SAE)
时间窗: up to 48 weeks
The occurrence of all adverse events (AE) and serious adverse events (SAE).
次要结局
- Disease control rate (DCR)(up to 48 weeks)
- Progression free survival (PFS)(up to 48 weeks)
- Overall survival (OS)(up to 48 weeks)
研究者
研究点 (36)
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