A Randomized, Controlled, Open-label, Multicenter, Phase Ш Clinical Study of the Efficacy and Safety of KN026 in Combination With HB1801 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 880
- 试验地点
- 1
- 主要终点
- Free-progression survival (PFS) as evaluated by BIRC (RECIST1.1).
研究概览
简要总结
This is a randomized, controlled, open-label, multicenter, phase Ш clinical study designed to compare the efficacy and safety of KN026 in combination with HB1801 to trastuzumab in combination with pertuzumab and docetaxel in the first-line treatment of subjects with HER2-positive recurrent or metastatic breast cancer. The statistical assumption for this study is superiority. The primary study endpoint was PFS as assessed by Blinded Independ Review Committee (BIRC).
详细描述
The purpose of this study is to assess the efficacy and safety of KN026 combined with HB1801 versus trastuzumab combined with pertuzumab and docetaxel as first-line treatment for HER2-positive recurrent or metastatic breast cancer. This study will establish an independent data monitoring committee (IDMC) to conduct safety assessments after approximately 20 subjects in the treatment group complete the first cycle of treatment. During the safety assessment period, the study will continue to enroll subjects, and safety review meetings will be at 1 year of randomization in the first subject. In addition, the IDMC plans to conduct one interim analysis of efficacy during the study period.
The primary study hypotheses are that the combination of KN026 combined with HB1801 is superior to trastuzumab combined with pertuzumab and docetaxel with respect to: Progression-free Survival (PFS) as assessed by the BIRC per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily enrolled in this study and signed an informed consent form (ICF).
- •Age ≥ 18 years.
- •Recurrent or metastatic breast cancer confirmed by histology and/or cytology.
- •Latest tumor tissue sample confirmed as HER2 positive by central laboratory testing.
- •No prior systemic chemotherapy and/or HER2-targeted therapy for recurrent or metastatic breast cancer.
- •Eastern Cooperative Oncology Group (ECOG) physical status score of 0 -
- •Presence of lesion (RECIST 1.1).
- •Adequate organ and bone marrow function
排除标准
- •Ineligible for any of the agents on the study
- •Untreated or unstable parenchymal metastases, spinal cord metastases or compression, or carcinomatous encephalitis.
- •Pregnant or lactating women.
- •Presence of other circumstances that may interfere with the subject's participation in the study procedures or are inconsistent with the maximum benefit of the subject's participation in the study or affect the results of the study: e.g., history of mental illness, drug or substance abuse, any other disease or condition of clinical significance, etc.
研究组 & 干预措施
KN026+HB1801
Subjects will receive an intravenous (IV) infusion of KN026 plus HB1801. All subjects are required to receive study treatment as planned until investigator-assessed loss of benefit, toxic intolerance, withdrawal of consent, loss to follow-up, or death, whichever occurrs first.
干预措施: Recombinant Humanized Bispecific antibody against HER2，KN026 (Drug)
KN026+HB1801
Subjects will receive an intravenous (IV) infusion of KN026 plus HB1801. All subjects are required to receive study treatment as planned until investigator-assessed loss of benefit, toxic intolerance, withdrawal of consent, loss to follow-up, or death, whichever occurrs first.
干预措施: HB1801 (Drug)
Trastuzumab + Pertuzumab + Docetaxel
On Day 1 of each 21-day cycle, patients will receive an intravenous (IV) infusion of Pertuzumab 840 mg loading dose followed by 420 mg per cycle, IV, D1, Q3W, in combination with trastuzumab 8 mg/kg loading dose followed by 6 mg/kg per cycle, IV, D1, Q3W and docetaxel 75 mg/m^2. All subjects are required to receive study treatment as planned until investigator-assessed loss of benefit, toxic intolerance, withdrawal of consent, loss to follow-up, or death, whichever occurred first.
干预措施: Pertuzumab (Drug)
Trastuzumab + Pertuzumab + Docetaxel
On Day 1 of each 21-day cycle, patients will receive an intravenous (IV) infusion of Pertuzumab 840 mg loading dose followed by 420 mg per cycle, IV, D1, Q3W, in combination with trastuzumab 8 mg/kg loading dose followed by 6 mg/kg per cycle, IV, D1, Q3W and docetaxel 75 mg/m^2. All subjects are required to receive study treatment as planned until investigator-assessed loss of benefit, toxic intolerance, withdrawal of consent, loss to follow-up, or death, whichever occurred first.
干预措施: Trastuzumab (Drug)
Trastuzumab + Pertuzumab + Docetaxel
On Day 1 of each 21-day cycle, patients will receive an intravenous (IV) infusion of Pertuzumab 840 mg loading dose followed by 420 mg per cycle, IV, D1, Q3W, in combination with trastuzumab 8 mg/kg loading dose followed by 6 mg/kg per cycle, IV, D1, Q3W and docetaxel 75 mg/m^2. All subjects are required to receive study treatment as planned until investigator-assessed loss of benefit, toxic intolerance, withdrawal of consent, loss to follow-up, or death, whichever occurred first.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Free-progression survival (PFS) as evaluated by BIRC (RECIST1.1).
时间窗: Up to approximately 4 years
次要结局
- Concentration of HB1801 in serum(Up to approximately 4 years)
- Objective response rate (ORR)(Up to approximately 4 years)
- Incidence of KN026 Anti-drug antibody (ADA) and neutralizing antibody (Nab) (if applicable)(Up to approximately 4 years)
- Frequency and severity of TEAE and SAE(Up to approximately 4 years)
- Concentration of KN026 in serum(Up to approximately 4 years)
- Overall survival (OS)(Up to approximately 4 years)
- Disease control rate (DCR)(Up to approximately 4 years)
- Duration of response (DoR)(Up to approximately 4 years)
- PFS (investigator assessment, RECIST1.1)(Up to approximately 4 years)