A Phase II Clinical Study of SSGJ-612 in Combination With a Human Epidermal Growth Factor Receptor 2 (HER2)-Targeted Antibody-Drug Conjugate (ADC) in Patients With Hormone Receptor (HR)-Positive, HER2-Low or HER2-Ultralow Expression Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study is a phase II clinical trial of SSGJ-612 combined with a human epidermal growth factor receptor 2 (HER2)-targeted antibody-drug conjugate (ADC) in patients with hormone receptor (HR)-positive, HER2-low or HER2-ultralow metastatic breast cancer.
详细描述
The study is divided into two parts: Participants in Part 1: Breast cancer patients who have received at least one line of chemotherapy for metastatic disease; Participants in Part 2: Breast cancer patients who have not received any chemotherapy for metastatic disease.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation in this study, signed informed consent form, good treatment compliance, and willingness to cooperate to complete all trial procedures.
- •Expected survival duration ≥ 3 months.
- •Histopathologically confirmed breast cancer meeting all of the following criteria simultaneously:
- •Metastatic tumor;
- •Tumor samples tested by central laboratory confirmed as HER2-low or HER2 ultra-low expression;
- •No prior test results reporting HER2 positivity;
- •Tumor sample testing confirms hormone receptor-positive (HR+) status.
- •Patients must satisfy either of the following conditions:
- •Disease progression within 6 months after initiation of first-line endocrine therapy combined with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors for metastatic disease;
- •Received at least 2 lines of prior endocrine therapy for metastatic disease, with disease progression post-treatment.
- •Participants in Part 1: Breast cancer patients who have received at least one line of chemotherapy for metastatic disease; Participants in Part 2: Breast cancer patients who have not received any chemotherapy for metastatic disease.
- •At least one repeatedly and accurately measurable tumor lesion as target lesion assessed per RECIST v1.1 criteria.
排除标准
- •Uncontrolled or severe cardiovascular disease.
- •History of interstitial lung disease (ILD)/pneumonia requiring corticosteroid therapy (non-infectious), or current ILD/pneumonia, or suspected ILD/pneumonia not excluded by screening imaging.
- •Presence of pulmonary-specific, clinically significant comorbid conditions.
- •Presence of spinal cord compression, or clinically active central nervous system metastases.
- •Female patients who are pregnant, breastfeeding, or planning pregnancy.
- •Patients who received investigational drug therapy in another clinical trial within 30 days prior to first study drug administration, or who are concurrently enrolled in another clinical trial. Note: Exclusions include participation in observational (non-interventional) clinical trials, or being in the follow-up phase of an interventional clinical trial.
- •Presence of drug abuse, or other diseases (e.g., psychiatric disorders) that, in the investigator's judgment, may interfere with patient participation in the trial or affect the assessment of trial outcomes.
研究组 & 干预措施
Part 1
Breast cancer patients who have received at least one line of chemotherapy for metastatic disease
干预措施: SSGJ-612 (HER2-targeted antibody) (Drug)
Part 1
Breast cancer patients who have received at least one line of chemotherapy for metastatic disease
干预措施: HER2-targeted ADC (Drug)
Part 2
Breast cancer patients who have not received any chemotherapy for metastatic disease
干预措施: SSGJ-612 (HER2-targeted antibody) (Drug)
Part 2
Breast cancer patients who have not received any chemotherapy for metastatic disease
干预措施: HER2-targeted ADC (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 2 years
The primary efficacy end point
次要结局
- Incidence and Severity of Adverse Events (AEs)(2 years)
- Progression-Free-Survival (PFS)(2 years)