A Phase II Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients With Intolerable Adverse Reaction or Disease Progression on Standard of Care
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
This is a Phase II Study of HLX22 in Combination with Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression or Intolerable Adverse Reaction 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).
详细描述
experimental group: HLX22(15 mg/kg) + Trastuzumab Deruxtecan( 5.4 mg/kg), once every 3 weeks (Q3W).
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 —（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 on the day of signing the informed consent.
- •With histologically confirmed diagnosis of HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer.
- •HER2-low defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) as assessed by a central laboratory on metastatic tumor and was never previously HER2-positive，and was documented HR+ disease in the metastatic setting
- •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
- •Previous treatment with any HER2-target therapy
- •Uncontrolled or significant cardiovascular disease or infection
- •Lung-specific intercurrent clinically significant illnesses
- •Prior documented interstitial lung disease (ILD)/ pneumonitis that required steroids, current ILD/ pneumonitis, or suspected ILD/ pneumonitis
- •Patients with spinal cord compression or clinically active central nervous system metastases
研究组 & 干预措施
Experimental group
HLX22(15 mg/kg) + Trastuzumab Deruxtecan( 5.4 mg/kg), Q3W
干预措施: HLX22 (Drug)
Experimental group
HLX22(15 mg/kg) + Trastuzumab Deruxtecan( 5.4 mg/kg), Q3W
干预措施: Trastuzumab Deruxtecan (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to 5 years
Progression-Free Survival (PFS) assessed by IRRC (Independent Radiology Review Committee) per RECIST 1.1 . PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.
Objective response rate (ORR)
时间窗: Up to 2 years
Objective Response Rate (ORR) assessed by IRRC per RECIST v1.1. ORR is defined as the percentage of participants who have a Complete Response (\[CR\], disappearance of all evidence of disease) or Partial Response (\[PR\], regression of measurable disease and no new sites) per RECIST 1.1
次要结局
- PFS(Up to 5 years)
- ORR(Up to 2 years)
- Aderse events (AE)(Up to 5 years)