An Open, Multicenter Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Dalpiciclib, Fulvestrant, Bevacizumab or Letrozole/Anastrozole in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Objective response rate(The main end points of the second stage (efficacy expansion stage))
研究概览
简要总结
This study aims to evaluate the safety, tolerability, PK and preliminary anti-tumour activity of SHR-A1811 combined with other therapies in patients with HER2 low advanced or metastatic 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
- •Ability to give informed consent, signed and dated IRB/EC approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements
- •When signing the informed consent, the age is 18-75 years old (including both ends), female patients who have pathologically documented HER2 low breast cancer
- •ECOG Performance Status of 0 or 1
- •Patient must have adequate tumor sample for biomarker assessment
- •At least one measurable lesion
- •Adequate organ function
排除标准
- •There are untreated or active central nervous system (CNS) tumor metastases
- •There was a third space effusion that could not be controlled by drainage (such as a large number of ascites, pleural effusion and pericardial effusion)
- •Major surgery within 4 weeks prior to enrollment
- •Has multiple primary malignancies within 5 years, excluding cured basal cell carcinoma of skin, cervical carcinoma in situ, papillary thyroid carcinoma, etc
- •Has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out at screening
- •Uncontrolled intercurrent illness
- •Uncontrolled or significant cardiovascular disease
- •Has known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
- •According to NCI-CTCAE v5.0 classification, those who have not recovered to grade Ⅰ toxicity caused by previous anti-tumour treatment
研究组 & 干预措施
SHR-A1811 combined with Dalpiciclib Isethionate Tablets
干预措施: SHR-A1811 & Dalpiciclib Isethionate Tablets (Drug)
SHR-A1811 combined with Fulvestrant
干预措施: SHR-A1811 & Fulvestrant (Drug)
SHR-A1811 combined with Bevacizumab injection
干预措施: SHR-A1811 & Bevacizumab injection (Drug)
结局指标
主要结局
Objective response rate(The main end points of the second stage (efficacy expansion stage))
时间窗: Until progression, assessed up to approximately 24 months
DLT(Phase I (dose-finding phase) main study endpoint)
时间窗: At the end of cycle 1(each cycle is 28 days for SHR-A1811+ fulvestrant; each cycle is 21 days for SHR-A1811+other therapies.
AE(Phase I (dose-finding phase) main study endpoint)
时间窗: Up to follow-up period, approximately 24 months
Incidence and severity of serious adverse events (SAE)(Phase I (dose-finding phase) main study endpoint)
时间窗: Up to follow-up period, approximately 24 months
次要结局
- Progression-free survival (PFS)(Until progression or death, assessed up to approximately 24 months)
- SHR-A1811 sparse PK concentrations in serum(While on study drug up to study completion, approximately 24 months)
- Dalpiciclib sparse PK concentrations in plasm(While on study drug up to study completion, approximately 24 months)
- Incidence of neutralizing antibody (NAb) to SHR-A1811 over time(Up to follow-up period, approximately 24 months)
- Incidence of anti-drug antibodies (ADA) to SHR-A1811 over time(Up to follow-up period, approximately 24 months)
- Duration of response (DoR)(Until progression or death, assessed up to approximately 24 months)