Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
The prognosis of recurrent and metastatic triple negative breast cancer (TNBC) is poor, and chemotherapy is still the main treatment for TNBC. Some studies have shown that combination therapy of antibodies targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed cell death-1 (PD-1) significantly improves clinical benefit over PD-1 antibody alone. However, broad application of this combination has been limited by toxicities. Cadonilimab is a humanized immunoglobulin G1 bispecific antibody targeting PD-1 and CTLA-4. It mutates to eliminate Fc receptor and complement-mediated cytotoxic effects. The purpose of this study is to evaluate the efficacy and safety of Cadonilimab combined with chemotherapy as a first or second-line treatment of recurrent and metastatic TNBC. This study is a multicenter, single arm, phase II, non randomized, open label, Simon two-stage design. It is planned to enroll 27 late stage TNBC patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent or metastatic TNBC patients;
- •TNBC defined by immunohistochemistry as ER<1%, PR<1%, Her2=0~1+, or 2+ while HER2 Fish test shows no amplification；
- •Previous received no or only first line chemotherapy treatment for recurrent or metastatic TNBC；When the time between cancer metastasis and the end of adjuvant chemotherapy exceeds 1 year, the systemic chemotherapy for metastasis treatment is recorded as first-line treatment; When less than 1year, the systemic chemotherapy for metastasis treatment is recorded as second-line treatment；
- •ages 18 to 75 years at the time of signing the informed consent form (ICF);
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- •expected survival of ≥3 months; at least one measurable lesion per RECIST (version1.1);
- •acceptable renal and liver function;
排除标准
- •They had received ICIs (i.e., anti-PD-1 antibodies, anti-PD-L1 antibodies, and anti-CTLA-4 antibodies.)；
- •Patients with active central nervous system (CNS) metastatic lesions or meningeal metastases；
- •Patients with an active autoimmune disease that requires systemic treatment in the past two years；
- •A known history of primary immunodeficiency；
- •Pregnant or lactating women；
- •Previous or current abnormalities of any disease, treatment, laboratory tests may confuse the study results, affect the subject's participation in the study
研究组 & 干预措施
Experimental Arm
干预措施: Cadonilimab (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Up to 2 years
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
次要结局
- AE(From the time of informed consent signed through 90 days after the last dose of drug)