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抗 HER2 双特异性抗体 ZW25 与化疗联合使用/不使用替雷利珠单抗的活性

2026年8月12日 更新者：BeiGene

在晚期 HER2 阳性乳腺癌或胃/胃食管交界处腺癌患者中调查抗 HER2 双特异性抗体 ZW25 联合化疗联合/不联合 Tislelizumab 的安全性、耐受性、药代动力学和初步抗肿瘤活性的 1b/2 期研究

该研究的目的是评估 ZW25 联合多西紫杉醇在人类表皮生长因子受体 2 (HER2) 阳性乳腺癌参与者中的安全性、耐受性和初步抗肿瘤活性，以及​​ ZW25 联合替雷利珠单抗和化疗在患有乳腺癌的参与者中的安全性、耐受性和初步抗肿瘤活性。 HER2 阳性胃/胃食管结合部 (GEJ) 腺癌

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

71

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100142
        • Beijing Cancer Hospital
      • Beijing、Beijing Municipality、中国、100071
        • The Affiliated Hospital of Military Medical Sciences
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国、400030
        • Chongqing Cancer Hospital
    • Guangdong
      • Guangzhou、Guangdong、中国、510120
        • Guangdong Provincial Peoples Hospital Huifu Branch
    • Jiangxi
      • Nanchang、Jiangxi、中国、330009
        • The Third Hospital of Nanchang
    • Jilin
      • Changchun、Jilin、中国、130021
        • Jilin cancer hospital
    • Liaoning
      • Shenyang、Liaoning、中国、110042
        • Liaoning Cancer Hospital and Institute
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310022
        • Zhejiang Cancer Hospital
  • 台湾
      • Kaohsiung City、台湾、83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung、台湾、40447
        • China Medical University Hospital
      • Tainan、台湾、704
        • National Cheng Kung University Hospital
      • Taipei、台湾、11217
        • Taipei Veterans General Hospital
      • Taipei、台湾、100225
        • National Taiwan University Hospital East Campus
  • 韩国
    • Gyeonggi-do
      • Goyang-si、Gyeonggi-do、韩国、10408
        • National Cancer Center
      • Seongnam-si、Gyeonggi-do、韩国、13620
        • Seoul National University Bundang Hospital
    • Seoul Teugbyeolsi
      • Seoul、Seoul Teugbyeolsi、韩国、03080
        • Seoul National University Hospital
      • Seoul、Seoul Teugbyeolsi、韩国、05505
        • Asan Medical Center
      • Seoul、Seoul Teugbyeolsi、韩国、06273
        • Gangnam Severance Hospital, Yonsei University Health System
      • Seoul、Seoul Teugbyeolsi、韩国、06351
        • Samsung Medical Center
      • Seoul、Seoul Teugbyeolsi、韩国、03722
        • Severance Hospital Yonsei University Health System
      • Seoul、Seoul Teugbyeolsi、韩国、08308
        • Korea University Guro Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

描述

关键纳入标准：

  1. 疾病诊断和前期治疗：

    1. 队列 1（一线乳腺癌治疗队列）：

      • 经组织学或细胞学证实为不可切除、局部晚期、复发或转移性乳腺腺癌且适合化疗的女性参与者。 局部复发的疾病不能以治愈为目的进行切除。
      • 人类表皮生长因子受体 2 (HER2) IHC 3+ 或原位杂交对存档肿瘤组织或新鲜活检样本呈阳性。
      • 既往未接受过针对局部晚期不可切除或转移性疾病的全身抗癌治疗。

    2. 队列 2（一线胃/胃食管交界处腺癌治疗队列）：

      • 经组织学或细胞学证实的不可切除、局部晚期、复发或转移的胃或胃食管交界处腺癌
      • HER2 IHC 3+ 或 HER2 IHC 2+ 以及存档肿瘤组织或新鲜活检样本的原位杂交阳性。
      • 既往未接受过针对局部晚期不可切除或转移性疾病的全身抗癌治疗，包括任何已批准或正在研究的估计肾小球滤过率 (EGFR) 或抗 HER2 药物或疫苗、细胞毒性化疗或检查点抑制剂
  2. 至少 1 个根据 RECIST 1.1 版定义的可测量病变
  3. 东部肿瘤合作组 (ECOG) 绩效状态 ≤ 1
  4. 在筛选过程中，以下实验室值表明具有足够的器官功能：
  5. 在研究药物首次给药前 28 天内，通过超声心动图或多门采集扫描 (MUGA)（超声心动图是首选方法）确定基线时左心室射血分数 (LVEF) ≥ 50%

关键排除标准：

  1. 先前使用抗 PD-1、抗 PD-L1、抗 PD-L2 或任何其他特异性靶向 T 细胞共刺激或检查点通路的抗体或药物进行治疗

  2. 在任何治疗环境中批准或研究酪氨酸激酶/HER 抑制剂的历史

    A。除了曲妥珠单抗联合或不联合帕妥珠单抗用于队列 1 的新辅助或辅助治疗

  3. 活动性软脑膜疾病，未经治疗或不受控制的脑转移
  4. 研究药物首次给药前 ≤ 2 年的任何活动性恶性肿瘤，除了本试验中正在研究的特定癌症和任何已经治愈的局部癌症（例如，切除的基底细胞或鳞状细胞皮肤癌、浅表性膀胱癌、膀胱癌）子宫颈或乳房的位置）
  5. 在研究药物首次给药前 ≤ 14 天需要使用皮质类固醇（> 10 mg 泼尼松或等效药物）或其他免疫抑制药物进行全身治疗的任何病症

注意：不排除目前或以前接受过以下任何类固醇治疗的参与者：

  1. 肾上腺替代类固醇（每日剂量≤ 10 mg 泼尼松或等效药物）
  2. 全身吸收最小的局部、眼部、关节内、鼻内或吸入皮质类固醇
  3. 短期（≤ 7 天）皮质类固醇预防性处方（例如，用于造影剂过敏）或用于治疗非自身免疫性疾病（例如，由接触性过敏原引起的迟发型超敏反应）

注意：其他协议定义的包含/排除标准可能适用。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Cohort 1A: Breast Cancer: Zanidatamab 30 mg/kg + Docetaxel
Participants with HER2+ breast cancer received zanidatamab 30 mg/kg intravenously (IV) and docetaxel 75 mg/m^2 IV once every 3 weeks (Q3W) for an initial period of up to six cycles. After cycle 6, continuation of docetaxel treatment was at the discretion of the investigator. Zanidatamab was administered until disease progression, intolerable toxicity, or another criterion for treatment discontinuation was met.
药品：多西紫杉醇
静脉内给药
生物：扎尼达单抗
静脉注射
其他名称：
  • ZW25
实验性的：Cohort 1B: Breast Cancer: Zanidatamab 1800 mg + Docetaxel
Participants with HER2+ breast cancer received zanidatamab 1800 mg/kg IV and docetaxel 75 mg/m^2 IV Q3W for an initial period of up to six cycles. After cycle 6, continuation of docetaxel treatment was at the discretion of the investigator. Zanidatamab was administered until disease progression, intolerable toxicity, or another criterion for treatment discontinuation was met.
药品：多西紫杉醇
静脉内给药
生物：扎尼达单抗
静脉注射
其他名称：
  • ZW25
实验性的：Cohort 2A: Gastric/GEJC: Zanidatamab 30 mg/kg + Tislelizumab + CAPOX
Participants with HER2+ gastric / gastroesophageal junction cancer (GEJC) received zanidatamab 30 mg/kg IV and tislelizumab 200 mg IV once every 3 weeks until disease progression, intolerable toxicity, or another criterion for treatment discontinuation was met. Participants also received CAPOX chemotherapy (1000 mg/m^2 oral capecitabine twice daily for 14 days in each cycle and 130 mg/m^2 oxaliplatin IV once every 3 weeks) for up to 6 six cycles. After cycle 6, oxaliplatin was discontinued and continuation of capecitabine as maintenance treatment was at the investigator's discretion.
药品：卡培他滨
口服给药
药品：奥沙利铂
静脉注射
生物：扎尼达单抗
静脉注射
其他名称：
  • ZW25
生物：替雷利珠单抗
静脉注射
其他名称：
  • BGB-A317
实验性的：Cohort 2B: Gastric/GEJC : Zanidatamab 1800/2400 mg + Tislelizumab + CAPOX
Participants with HER2+ gastric / GEJC received zanidatamab 1800 mg (participants with body weight < 70 kg) or 2400 mg (participants with body weight ≥ 70 kg) IV and tislelizumab 200 mg IV Q3W until disease progression, intolerable toxicity, or another criterion for treatment discontinuation was met. Participants also received CAPOX chemotherapy (1000 mg/m^2 oral capecitabine twice daily for 14 days in each cycle and 130 mg/m^2 oxaliplatin IV once every 3 weeks) for up to 6 six cycles. After cycle 6, oxaliplatin was discontinued and continuation of capecitabine as maintenance treatment was at the investigator's discretion.
药品：卡培他滨
口服给药
药品：奥沙利铂
静脉注射
生物：扎尼达单抗
静脉注射
其他名称：
  • ZW25
生物：替雷利珠单抗
静脉注射
其他名称：
  • BGB-A317

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：From the first dose of study drug(s) to 30 days after the last dose; up to approximately 42 months

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatments, whether considered related to study treatments or not.

A serious AE (SAE) was any untoward medical occurrence that, at any dose - resulted in death, - was life threatening, - required hospitalization or prolongation of existing hospitalization, - resulted in disability/incapacity, - was a congenital anomaly/birth defect.
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 42 months
Objective Response Rate (ORR)
大体时间：Response was assessed every 6 weeks from cycle 1 day 1 for the first 36 weeks and then every 12 weeks thereafter; maximum time on study follow-up was 42months.

ORR is defined as the percentage of participants who had a best overall response of complete response or partial response per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Response was assessed every 6 weeks from cycle 1 day 1 for the first 36 weeks and then every 12 weeks thereafter; maximum time on study follow-up was 42months.

次要结果测量

结果测量
措施说明
大体时间
Duration of Response (DOR)
大体时间：From the start date of study treatment to the first documentation of progression or death, whichever occurs first, up to approximately 42 months
DOR is defined as the time from the first determination of an objective response until the first documentation of disease progression or death, whichever occurred first.
From the start date of study treatment to the first documentation of progression or death, whichever occurs first, up to approximately 42 months
Time to Response (TTR)
大体时间：From the start date of study treatment to the first documentation of response, whichever occurs first, up to approximately 42 months
Time to response is defined as the time from the start date of study treatment to the first determination of an objective response assessed by investigator per RECIST v 1.1.
From the start date of study treatment to the first documentation of response, whichever occurs first, up to approximately 42 months
Progression-free Survival (PFS)
大体时间：From the start date of study treatment to the first documentation of progression or death, whichever occurs first, up to approximately 42 months
PFS is defined as the time from the start date of study drug to the date of the first objectively documented tumor progression assessed by investigator per RECIST Version 1.1 or death, whichever occurred first.
From the start date of study treatment to the first documentation of progression or death, whichever occurs first, up to approximately 42 months
Disease Control Rate (DCR)
大体时间：Response was assessed every 6 weeks from cycle 1 day 1 for the first 36 weeks and then every 12 weeks thereafter; maximum time on study follow-up was 42 months.

DCR is defined as the percentage of participants with best overall response (BOR) of CR, PR, and stable disease by investigator per RECIST Version 1.1.

BOR is the best response recorded from the start of the study drug treatment until the end of treatment taking into account any requirement for confirmation.
Response was assessed every 6 weeks from cycle 1 day 1 for the first 36 weeks and then every 12 weeks thereafter; maximum time on study follow-up was 42 months.
Overall Survival (OS)
大体时间：From the start date of study treatment to the documented death date or the last known alive date, up to approximately 41 months
Time from the start date of study drug to the date of death due to any cause.
From the start date of study treatment to the documented death date or the last known alive date, up to approximately 41 months
Serum Concentration of Zanidatamab as a Function of Time
大体时间：Day 1 end of infusion of Cycle 1, 2, 5, 9, 17, 26 and 35. Each cycle is 21 days
Day 1 end of infusion of Cycle 1, 2, 5, 9, 17, 26 and 35. Each cycle is 21 days
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Timepoint (AUC(0-t)) of Zanidatamab
大体时间：Cycle 1: predose and 0, 2, 4, 24, 96, 168, and 336 hours postdose. Cycle 2: predose and 0, 168, and 336 hours postdose. Each cycle is 21 days.
Cycle 1: predose and 0, 2, 4, 24, 96, 168, and 336 hours postdose. Cycle 2: predose and 0, 168, and 336 hours postdose. Each cycle is 21 days.
Observed Maximum Plasma Concentration of Zanidatamab During a Sample Interval (Cmax)
大体时间：Cycle 1: predose and 0, 2, 4, 24, 96, 168, and 336 hours postdose. Cycle 2: predose and 0, 168, and 336 hours postdose. Each cycle is 21 days.
Cycle 1: predose and 0, 2, 4, 24, 96, 168, and 336 hours postdose. Cycle 2: predose and 0, 168, and 336 hours postdose. Each cycle is 21 days.
Observed Time to Maximum Plasma Concentration of Zanidatamab During a Sampling Interval (Tmax)
大体时间：Cycle 1: predose and 0, 2, 4, 24, 96, 168, and 336 hours postdose. Cycle 2: predose and 0, 168, and 336 hours postdose. Each cycle is 21 days.
Cycle 1: predose and 0, 2, 4, 24, 96, 168, and 336 hours postdose. Cycle 2: predose and 0, 168, and 336 hours postdose. Each cycle is 21 days.
Terminal Elimination Half-life (t1/2) of Zanidatamab
大体时间：Cycle 1: predose and 0, 2, 4, 24, 96, 168, and 336 hours postdose. Cycle 2: predose and 0, 168, and 336 hours postdose. Each cycle is 21 days.
Cycle 1: predose and 0, 2, 4, 24, 96, 168, and 336 hours postdose. Cycle 2: predose and 0, 168, and 336 hours postdose. Each cycle is 21 days.
Apparent Clearance After Oral Administration (CL/F) of Zanidatamab
大体时间：Cycle 1: predose and 0, 2, 4, 24, 96, 168, and 336 hours postdose
Cycle 1: predose and 0, 2, 4, 24, 96, 168, and 336 hours postdose
Number of Participants With Anti-zanidatamab Antibodies
大体时间：From the first dose of study drug(s) to 30 days after the last dose; up to approximately 42 months
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 42 months
Number of Participants With AEs and SAEs in Participants Who Entered the Long-term Extension Period
大体时间：From the first dose of study drug(s) to 30 days after the last dose; up to approximately 51 months
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 51 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

BeiGene

调查人员

  • 研究主任：Study Director、BeiGene

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年3月23日

初级完成 (实际的)

2023年12月7日

研究完成 (实际的)

2024年10月31日

研究注册日期

首次提交

2020年2月4日

首先提交符合 QC 标准的

2020年2月18日

首次发布 (实际的)

2020年2月19日

研究记录更新

最后更新发布 (实际的)

2026年9月2日

上次提交的符合 QC 标准的更新

2026年8月12日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • BGB-A317-ZW25-101
  • CTR20210237 (其他标识符：ChinaDrugTrials)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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