A Phase Ib，Open-labeled, Multi-center, Dose-exploring Trial of SHR-1210 (Anti-PD-1 Antibody) in Combination With Apatinib and Fluzoparib in Subjects With Recurrent and Metastatic Triple Negative Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
The study is being conducted to evaluate the tolerability, safety and efficacy of SHR-1210 in combination with Apatinib and Fluzoparib in subjects with recurrent and metastatic triple negative breast cancer
详细描述
Drug: SHR-1210 + Apatinib +Fluzoparib SHR-1210 will be administered as an intravenous infusion, Apatinib tablets will be given orally, Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity.
Treatment group ： PD-1 antibody SHR-1210 combination with apatinib and fluzoparib
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
- •Signed the informed consent.
- •Female aged ≥18 years old.
- •Histologically diagnosed patients with recurrent and metastatic triple negative breast cancer.
- •No more than 2-line chemotherapy failed at the stage of recurrence and metastasis .
- •Patients who have been treated with platinum-based regimen at the stage of recurrence/metastasis need non-disease progression (non-pd)during treatment
- •At least one measuring lesion that confirmed by RECIST v1.1 standard.
- •The patients can swallow pills.
- •Have a life expectancy of at least 12 weeks.
- •The functions of vital organs meet protocal requirements.
排除标准
- •Subjects had any history of active autoimmune disease .
- •Subjects had previously been treated with anti-PD-1 and PD-L1 antibodies, or was known to be allergic to antibody drugs, or had previously been treated with apatinib, or had previously been treated with PARP inhibitors.
- •Subjects have untreated central nervous system metastasis.
- •History of hypertension and antihypertensive medications are not well controlled.
- •Some clinical symptoms or diseases of the heart that are not well controlled.
- •History of immunodeficiency including HIV-positive.
- •Subjects had active infections.
研究组 & 干预措施
SHR-1210 + Apatinib +Fluzoparib
SHR-1210 will be administered as an intravenous infusion Apatinib tablets will be given orally Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity
干预措施: SHR-1210 + Apatinib +Fluzoparib (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: First cycle (28 days)
Dose Limiting Toxicity
次要结局
- 12-months overall survival rate(From the start of treatment to 1 year)
- Adverse Events and Serious Adverse Events(from the first drug administration to within 90 days for the last SHR-1210 dose)
- Duration of response (DoR)(up to 12 months (approx) from the start of treatment)
- Progression-Free-Survival(up to 12 months (approx) from the start of treatment)
- Overall Response Rate (ORR)(up to 12 months (approx) from the start of treatment)
- Disease Control Rate(up to 12 months (approx) from the start of treatment)