A Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of EG017 in Androgen Receptor-positive, Estrogen Receptor-positive, and Human Epidermal Growth Factor Receptor-2-negative Patients With Advanced Breast Cancer.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 5
- 主要终点
- Safety and Tolerability of EG017 as Measured by the Number of Participants Experiencing Dose-limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs).
研究概览
简要总结
To evaluate the safety, tolerability, pharmacokinetics and efficacy of EG017 in androgen receptor-positive, estrogen receptor-positive, and human epidermal growth factor receptor-2-negative patients with advanced breast cancer.
详细描述
The major aims of the study are to define the safety profile of this new drug, and to determine a recommended.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, 18-75 years old;
- •Expected survival ≥ 12 weeks;
- •Subjects with ECOG score of physical state 0~1;
- •Histologically confirmed recurrent or metastatic advanced breast cancer;
排除标准
- •Those who have had a severe allergic reaction to any drug or its components in this study in the past;
- •Present with primary central nervous system (CNS) malignancies; Subjects with CNS metastasis who have failed local treatment (except asymptomatic BMS, or symptomatic BMS with complete remission of symptoms ≥ 2 weeks after treatment for BMS);
- •Has any disease or syndrome that requires or is likely to require systemic steroid therapy during the study period;
- •Gastrointestinal disorders or gastrointestinal diseases will significantly affect the absorption of test drugs (such as ulcerative disease, uncontrolled vomiting, diarrhea, malabsorption syndrome, biliary drainage status, etc.), or subjects cannot take drugs orally:
研究组 & 干预措施
EG017
70 subjects: Part Ia 10 subjects: A total of 3 dose groups of 6 mg/day, 18 mg/day, 24 mg/day are planned. Once a day, each treatment cycle was administered for 28 days.
Part Ib 60 subjects: A total of 2 dose groups of 18 mg/day, 24 or 12mg/day are planned. Once a day, each treatment cycle was administered for 28 days.
干预措施: EG017 (Drug)
结局指标
主要结局
Safety and Tolerability of EG017 as Measured by the Number of Participants Experiencing Dose-limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs).
时间窗: 28 Days
The CTCAE criteria will be used to assess adverse events on this trial.
The effectiveness of EG017 in humans was evaluated by clinical benefit rate
时间窗: 24 Weeks
The number and proportion of subjects in clinical remission at 24 weeks after administration were calculated
次要结局
未报告次要终点