A Phase II Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- ORR
研究概览
简要总结
This is a Phase II Study of HLX43 in Hormone Receptor Positive，HER-2 negative Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression on Standard of Care. Eligible subjects will be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first)
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Male/female who are at least 18 years of age and and no more than 75 years old on the day of signing the informed consent.
- •With histologically confirmed diagnosis of HER2-negative, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer.
- •Must have experienced disease progression after receiving at least one line of endocrine therapy for advanced or metastatic disease.
- •Had measurable disease according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
- •ECOG PS: 0-
- •Expected survival ≥ 6 months.
- •Had adequate organ function
排除标准
- •Patients with other malignant tumors within 3 years before the randomization
- •Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/pneumonitis
- •Lung-specific intercurrent clinically significant illnesses
- •Uncontrolled or significant cardiovascular disease or infection
- •Prior adverse events leading to permanent discontinuation of immunotherapy; or prior immune-related pneumonia or immune-related myocarditis of grade ≥2.
研究组 & 干预措施
HLX43 DOSE1
Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until disease progression and loss of benifit, initiation of a new anti-tumor therapy, death,emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first).
干预措施: HLX43 (Drug)
HLX43 DOSE2
Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until disease progression and loss of benifit, initiation of a new anti-tumor therapy, death,emergence of intolerable toxicity, or withdrawal of informed consent (whichever occurs first).
干预措施: HLX43 (Drug)
结局指标
主要结局
ORR
时间窗: Up to 24WEEK
Objective response rate (ORR) assessed by IRRC (Independent Radiology Review Committee) per RECIST 1.1
PFS
时间窗: Up to 5 years
Progression-Free Survival (PFS) assessed by IRRC (Independent Radiology Review Committee) per RECIST 1.1
次要结局
未报告次要终点