NCT06662760招募中1 期
A Phase I Clinical Study of TQB3002 in Patients With Advanced Cancers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 11
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
This is a Phase I study to evaluate the safety, tolerability, and efficacy of TQB3002 in subjects with advanced cancers
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
- •Subjects voluntarily joined this study, signed the informed consent form, and had good compliance；
- •Age: ≥ 18 years old; Eastern Cooperative Oncology Group (ECOG) score: 0-1 ; Expected survival of more than 3 months；
- •Histologically or cytologically diagnosed with advanced cancers
- •Subjects with advanced malignancies who have failed standard therapy or lack effective treatment
- •Major organs are functioning well；
- •Female and male subjects of childbearing potential should agree to practice contraception for the duration of the study and for 6 months after the end of the study.
排除标准
- •Current concomitant presence of other malignancies within 5 years prior to the first dose；
- •Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy
- •Significant surgical treatment, biopsy, or significant traumatic injury within 4 weeks prior to the first dose
- •Long-term unhealed wounds or fractures
- •Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose
- •Swallowing dysfunction, active gastrointestinal diseases or other diseases that significantly affect the absorption, distribution, metabolism and excretion of the study drug, or previous subtotal gastrectomy
- •A history of psychotropic drug abuse and cannot be abstained from or have a mental disorder
- •Subjects with any severe and/or uncontrolled disease
研究组 & 干预措施
TQB3002 Tablets
Experimental
TQB3002 Tablets, 28 days as a treatment cycle
干预措施: TQB3002 Tablets (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: During the first 28 days
DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle(28days) of treatment.
Maximum tolerated dose (MTD)
时间窗: During the first 28 days
MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
次要结局
- Half-life (T1/2)(Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration)
- The area under the curve (AUC)(Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration)
- Apparent Plasma Clearance (CL)(Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration)
- Apparent volume of distribution (Vz)(Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration)
- Minimum concentration (Cmin)(Before administration (-1 hour ~ 0 hour), 0.5, 1, 2, 3, 4, 6, 8h , 12, 24, 48, 72, 96 and 168 hours after administration)
研究者
研究点 (11)
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