NCT06578286尚未招募2 期
Evaluate the Efficacy and Safety of ARX788 in Patients With HER2-positive Advanced Breast Cancer Whose Disease Has Progressed Following T-DXd Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 44
- 主要终点
- Objective remission rate (ORR)
研究概览
简要总结
A single arm, phase 2 Study of ARX788 in HER2-positive metastatic breast cancer patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 75 years old (including upper and lower limits), male or female;
- •Unresectable locally advanced, recurrent or metastatic BC;
- •Tissue samples determined to be HER2 positive (defined as IHC3+ or FISH+);
- •Received T-DXd treatment in the advanced stage;
- •Adequate bone marrow, liver, kidney and coagulation function;
- •Voluntarily sign the informed consent, have good compliance and are willing to comply with the follow-up visit.
排除标准
- •With meningeal metastases or disseminated brain metastases or active brain metastases;
- •Has interstitial lung disease requiring steroid therapy, a history of drug-induced interstitial lung disease, a history of radiation pneumonitis, or any evidence indicating clinically active interstitial lung disease;
- •Has any eye disease that require medical intervention such as keratitis, corneal diseases or active eye infection;
- •Has cardiac insufficiency;
- •Has received any systemic anti-tumor therapy (with the exception of endocrine therapy, with an interval of at least 7 days) within 28 days (or at least 5 half-lives) before the first use of the investigational product;
研究组 & 干预措施
ARX788
Experimental
ARX788，1.5 mg/kg IV infusion on Day 1 of each 21-day treatment cycle
干预措施: ARX788 (Drug)
结局指标
主要结局
Objective remission rate (ORR)
时间窗: Until progression, assessed up to approximately 24 months
The proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1.
次要结局
- Disease control rate (DCR)(Baseline through end of study, assessed up to 24 months])
- Duration of relief (DOR)(Until progression, assessed up to approximately 24 months)
- Overall survival (OS)(Until death, assessed up to approximately 50 months)
- The number of subjects experiencing adverse event TEAEs(Up to follow-up period, approximately 50 months)
- Progression-free survival (PFS)(Until progression or death, assessed up to approximately 36 months])
研究者
Jian Zhang,MD
Chief Physician
Fudan University
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