NCT05824325进行中（未招募）1 期
Different Targeted Antibody-drug Conjugates for HER2 Ultra-low or no Expression Advanced Breast Cancer: a Phase Ⅰb/Ⅱ Study（GALAXY）
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)- Phase 2
研究概览
简要总结
This is a phaseⅠb/Ⅱ, open-label, two-arm parallel study evaluating the efficacy and safety of different targeted antibody-drug conjugates for HER2 ultra-low or no expression advanced breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •ECOG Performance Status of 0 or 1
- •Pathologically documented breast cancer that:
- •is advanced or metastatic
- •is histologically confirmed to be HER2 IHC 0 (ISH- or untested)
- •was never previously HER2-positive (IHC 3+ or ISH+) At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.
- •Disease progression on at least 1 previous line of chemotherapy for recurrent/metastatic breast cancer. Subjects with HER2-negative and hormone-receptor positive tumors must have progressed after at least 1 line of endocrine therapy with or without CDK4/6 inhibitor.
- •Has protocol-defined adequate organ and bone marrow function. Ability to understand and willingness to sign a written informed consent document.
排除标准
- •Has previously been treated with any anti-HER2 therapy. Known prior severe hypersensitivity to investigational product or any component in its formulation and other monoclonal antibodies.
- •Any major surgery, radiotherapy, chemotherapy, immunotherapy or molecular targeted therapy, biotherapy or other drug clinical trial within 4 weeks; received endocrine therapy within 2 weeks before the first study drug administration.
- •History of other malignancy than breast cancer within 5 years prior to screening (except for cured skin basal cell carcinoma and cervical carcinoma in situ).
- •Meningeal metastasis or active brain parenchymal metastasis. Any concurrent use of immunosuppressant or systemic corticosteroid treatment to achieve immunosuppression purpose (dose of > 10mg/day prednisone or equivalent), and still in use within 2 weeks before the first study drug administration.
- •Has uncontrolled intercurrent illness or significant cardiovascular disease. History of clinically significant lung diseases. History of immunodeficiency, including HIV positive. Known active hepatitis B virus or hepatitis C virus infection. Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study.
研究组 & 干预措施
Experimental: HER2 ADC
Experimental
Patients diagnosed with HER2 ultra-low or no expression are recruited
干预措施: SHR-A1811 (Drug)
Experimental: TROP2 ADC
Experimental
Patients diagnosed with HER2 ultra-low or no expression are recruited.
干预措施: TROP2 ADC (Drug)
结局指标
主要结局
Objective Response Rate (ORR)- Phase 2
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.
Occurrence of adverse events (AEs)- Phase 1
时间窗: Up to follow-up period, approximately 24 months
Occurrence of AEs in Phase 1 graded according to CTCAE v5.0
次要结局
- Duration of Response (DoR)(Until progression, assessed up to approximately 24 months)
- Clinical Benefit Rate (CBR)(Until progression or death, assessed up to approximately 24 months)
- Overall Survival (OS)(Until death, assessed up to approximately 24 months)
- Progression Free Survival (PFS(Until progression, assessed up to approximately 24 months)
- Safety(Up to follow-up period, approximately 24 months)
- Disease Control Rate (DCR)(Baseline through end of study, assessed up to 24 months)
- Exploratory analyses(Baseline until disease progression or loss of clinical benefit, assessed up to 24 months)
研究者
Jian Zhang,MD
Chief Physician
Fudan University
研究点 (1)
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