此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

一项在患有不同类型晚期癌症（HER2 基因发生变化的实体瘤）的人群中测试不同剂量 BI 1810631 的研究

2026年10月27日 更新者：Boehringer Ingelheim

BI 1810631 作为具有 HER2 异常的晚期或转移性实体瘤患者的单一疗法的开放标签、I 期剂量递增试验、剂量确认和扩展

The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful.

The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene.

The purpose of the first study part is to find the highest dose of a medicine called zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink.

In this study, zongertinib is given to people for the first time. Participants take zongertinib as tablets once a day or twice a day.

The participants are in the study for as long as they benefit from and can tolerate treatment.

Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by zongertinib.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

554

阶段

  • 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。

学习联系方式

  • 姓名：Additional US locations available on demand. Please contact for options.
  • 电话号码：1-800-243-0127

研究联系人备份

学习地点

  • 中国
      • Beijing、中国、100036
        • 完全的
        • Beijing Cancer Hospital
      • Changchun、中国、130021
        • 主动，不招人
        • The First Hospital of Jilin University
      • Changchun、中国、130012
        • 完全的
        • Jilin Province Cancer Hospital
      • Fuzhou、中国、350014
        • 主动，不招人
        • Fujian Cancer Hospital
      • Guangzhou、中国、510080
        • 主动，不招人
        • Guangdong Provincial People's Hospital
      • Hangzhou、中国、310022
        • 主动，不招人
        • Zhejiang Cancer Hospital
      • Hangzhou、中国、310003
        • 主动，不招人
        • The First Affiliated Hospital, Zhejiang University
      • Harbin、中国、150081
        • 主动，不招人
        • Harbin Medical University Cancer Hospital
      • Nanning、中国、530021
        • 完全的
        • The Affiliated Cancer Hospital, Guangxi Medical University
      • Shanghai、中国、200030
        • 完全的
        • Shanghai Chest Hospital
      • Wuhan、中国、430030
        • 主动，不招人
        • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
      • Wuhan、中国、430022
        • 主动，不招人
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Xiamen、中国、361003
        • 完全的
        • First Affiliated Hospital of Xiamen University
      • Zhengzhou、中国、450052
        • 主动，不招人
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou、中国、450008
        • 主动，不招人
        • Henan Cancer Hospital
  • 以色列
      • Haifa、以色列、3109601
        • 完全的
        • Rambam Medical Center
      • Kfar Saba、以色列、44281
        • 主动，不招人
        • Meir Medical Center
      • Tel Aviv、以色列、6423906
        • 主动，不招人
        • Sourasky Medical Center
      • Tel HaShomer、以色列、52621
        • 完全的
        • The Chaim Sheba Medical Center Tel HaShomer
  • 奥地利
      • Linz、奥地利、4020
        • 完全的
        • Ordensklinikum Linz GmbH
  • 德国
      • Augsburg、德国、86156
        • 完全的
        • Universitätsklinikum Augsburg
      • Cologne、德国、50937
      • Dresden、德国、01307
      • Giessen、德国、35392
      • Oldenburg、德国、26121
  • 意大利
      • Candiolo (TO)、意大利、10060
        • 完全的
        • Istituto Di Candiolo
      • Naples、意大利、80131
        • 完全的
        • Istituto Nazionale IRCCS Tumori Fondazione Pascale
      • Parma、意大利、43100
        • 完全的
        • Azienda Ospedaliera Unversitaria di Parma
  • 新加坡
      • Singapore、新加坡、169610
      • Singapore、新加坡、119228
        • 完全的
        • National University Hospital-Singapore-22806
  • 日本
      • Chiba, Kashiwa、日本、277-8577
        • 招聘中
        • National Cancer Center Hospital East
        • 接触：
      • Ehime, Matsuyama、日本、791-0280
        • 招聘中
        • Shikoku Cancer Center
        • 接触：
      • Hiroshima, Hiroshima、日本、734-8551
        • 招聘中
        • Hiroshima University Hospital
        • 接触：
      • Osaka, Osaka、日本、541-8567
        • 招聘中
        • Osaka International Cancer Institute
        • 接触：
      • Osaka, Sakai、日本、590-0197
        • 招聘中
        • Kindai University Hospital
        • 接触：
      • Shizuoka, Hamamatsu、日本、431-3192
        • 招聘中
        • Hamamatsu University Hospital
        • 接触：
      • Tokyo, Chuo-ku、日本、104-0045
        • 招聘中
        • National Cancer Center Hospital
        • 接触：
  • 比利时
      • Anderlecht/Brussels-Capital、比利时、1070
        • 主动，不招人
        • Brussels - HOSP Jules Bordet
  • 法国
      • Bron、法国、69677
        • 主动，不招人
        • Hopital Louis Pradel
      • Lyon、法国、69373
        • 主动，不招人
        • CTR Leon Berard
      • Marseille、法国、13385
        • 主动，不招人
        • HOP Timone
      • Paris、法国、75005
        • 主动，不招人
        • INS Curie
      • Rennes、法国、35000
        • 主动，不招人
        • HOP Pontchaillou
      • Villejuif、法国、94805
        • 主动，不招人
        • Institut Gustave Roussy
  • 澳大利亚
    • New South Wales
      • Macquarie Park、New South Wales、澳大利亚、2109
        • 完全的
        • Macquarie University
  • 瑞典
      • Stockholm、瑞典、171 76
        • 完全的
        • Karolinska Universitetssjukhuset Solna
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35233
    • California
      • Beverly Hills、California、美国、90212
        • 完全的
        • Precision NextGen Oncology
      • Duarte、California、美国、91010
      • Huntington Beach、California、美国、92648
        • 完全的
        • City of Hope - Seacliff
      • Irvine、California、美国、92618
        • 完全的
        • City of Hope-Irvine-69674
      • Los Angeles、California、美国、90067
      • Orange、California、美国、92868
      • Sacramento、California、美国、95817
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20007
    • Florida
      • Fort Lauderdale、Florida、美国、33308
    • Georgia
      • Atlanta、Georgia、美国、30322
    • Hawaii
      • Honolulu、Hawaii、美国、96813
    • New York
      • New York、New York、美国、10016
        • 招聘中
        • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
        • 接触：
    • North Carolina
      • Durham、North Carolina、美国、27710
    • Ohio
      • Cleveland、Ohio、美国、44195
    • Tennessee
      • Nashville、Tennessee、美国、37203
        • 招聘中
        • Sarah Cannon Research Institute-Nashville-48456
        • 接触：
    • Texas
      • Dallas、Texas、美国、75230
      • Houston、Texas、美国、77030
        • 招聘中
        • The University of Texas MD Anderson Cancer Center
        • 接触：
    • Virginia
      • Fairfax、Virginia、美国、22031
    • Washington
      • Seattle、Washington、美国、98109
  • 英国
      • London、英国、SW3 6JJ
        • 主动，不招人
        • The Royal Marsden Hospital, Chelsea
      • London、英国、W12 0HS
        • 主动，不招人
        • Hammersmith Hospital
      • Sutton、英国、SM2 5PT
        • 主动，不招人
        • The Royal Marsden Hospital, Sutton
  • 荷兰
      • Amsterdam、荷兰、1066 CX
      • Leiden、荷兰、2333 ZA
        • 主动，不招人
        • Leids Universitair Medisch Centrum (LUMC)
  • 葡萄牙
      • Porto、葡萄牙、4100-180
        • 完全的
        • Hospital CUF Porto
  • 西班牙
      • Barcelona、西班牙、08035
        • 主动，不招人
        • Hospital Universitari Vall d'Hebron
      • L'Hospitalet de Llobregat、西班牙、08907
        • 主动，不招人
        • Hospital Duran i Reynals
      • Madrid、西班牙、28041
        • 主动，不招人
        • Hospital Universitario 12 de Octubre
      • Madrid、西班牙、28007
        • 完全的
        • Hospital General Universitario Gregorio Marañón
      • Málaga、西班牙、29010
        • 主动，不招人
        • Hospital Universitario Virgen de la Victoria
      • Valencia、西班牙、46010
        • 主动，不招人
        • Hospital Clinico Universitario de Valencia
  • 韩国
      • Chungju、韩国、28644
        • 招聘中
        • Chungbuk National University Hospital
        • 接触：
      • Seongnam、韩国、13620
        • 招聘中
        • Seoul National University Bundang Hospital
        • 接触：
      • Seoul、韩国、05505
      • Seoul、韩国、06351
        • 招聘中
        • Samsung Medical Center
        • 接触：
      • Seoul、韩国、03722
        • 主动，不招人
        • Severance Hospital
  • 香港
      • Hong Kong、香港
        • 主动，不招人
        • Queen Mary Hospital
      • Hong Kong、香港、999077
        • 主动，不招人
        • Prince of Wales Hospital-Hong Kong-20715

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

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy. Patient must show presence of at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.

  • Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 (ECOG=2 only for Cohorts 6, 7 and 9) .

  • Availability and patient willingness to provide a sample of tumour for confirmation of the patient´s Human epidermal growth factor receptor 2 (HER2) status. This sample can be archival material obtained at any time prior to study enrollment.

  • Patient willing and able to comply with the protocol requirements for tumour biopsies (biopsies from brain metastases are not allowed).

  • Adequate organ function defined as all of the following:

    • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (≥ 1.5 x 10^3/μL) (≥ 1500/mm^3); haemoglobin ≥ 9.0 g/dL (≥ 90 g/L) (≥ 5.6 mmol/L); platelets ≥ 100 x 10^9/L (100 x 10^3/μL) (100 x 10^3/mm3) without the use of hematopoietic growth factors within 4 weeks of start of trial medication.
    • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), except for patients with Gilbert's syndrome: total bilirubin ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN.
    • Estimated Glomerular Filtration Rate (eGFR) ≥ 50 mL/min - calculated using Chronic Kidney Disease Epidemiology (CKD-EPI) formula (≥ 30 mL/min/1.73m² for cohorts 6, 8, and 9).
    • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases.
    • Alkaline Phosphatase < 5 x ULN.

  • Recovered from any previous therapy-related toxicity to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at start of treatment (except for alopecia, stable sensory neuropathy and hypothyroidism (patients on thyroid replacement therapy) which must be ≤ CTCAE Grade 2)

  • Life expectancy of at least 12 weeks at the start of treatment in the opinion of the investigator.

  • At least 18 years of age at the time of consent or over the legal age of consent in countries where that is greater than 18 years.

  • Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.

  • Male or female patients. Women of childbearing potential (WOCBP) and men who are able to father a child must be ready and able to use highly effective methods of birth control per International Council on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.

Additional inclusion criteria for Phase Ia

  • Patients with a documented diagnosis of HER2 aberration: overexpression OR gene amplification OR non-synonymous somatic mutation OR gene rearrangement involving HER2 or Neuregulin 1 (NRG1)
  • Patient who has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted, or not be a suitable candidate for, available treatment options known to prolong survival for their disease

Additional inclusion criteria for Phase Ib - Cohort 1 only

  • Non-squamous non-small cell lung cancer (NSCLC) patients with documented human epidermal growth factor receptor 2 (HER2) mutation in the tyrosine kinase domain (TKD) as per local lab results.
  • Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy. Patients with non-squamous NSCLC harboring additionally genomic aberrations for which approved targeted therapy is available as standard of care, must have received prior treatment with an approved targeted therapy.

Additional inclusion criteria for Phase Ib - Cohort 2 only

  • Non-squamous NSCLC patient with a documented HER2 mutation in the tyrosine kinase domain (TKD) as per local lab results.
  • Treatment naïve for non-squamous NSCLC.

Additional inclusion criteria for Phase Ib - Cohort 3 only

  • NSCLC Patient with a documented HER2 mutation outside of the tyrosine kinase domain (TKD) as per local lab results or squamous NSCLC patient with mutation in the TKD as per local lab results. After implementation of CTP v8, only non-squamous NSCLC patients with a documented activating HER2 mutation outside of the tyrosine kinase domain (TKD) as per local lab results.
  • Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy. Patients with NSCLC harboring additionally genomic aberrations for which approved targeted therapy is available as standard of care, must have received prior treatment with an approved targeted therapy. After implementation of CTP v8, patients who had received, in the advanced/metastatic setting, at least one line of systemic therapy OR patients who are treatment naïve for non-squamous NSCLC (no prior systemic therapy, immunotherapy or targeted therapy for stage IIIB or IV adenocarcinoma).

Additional inclusion criteria for Phase Ib - Cohort 4 only

  • NSCLC patients with documented HER2 mutation in the TKD as per local lab results.
  • NSCLC patients who are either treatment naïve or who had received any prior line of treatment, in the advanced/metastatic setting. Patients with NSCLC harboring additional genomic aberrations for which approved targeted therapy is available as standard of care, must have received prior treatment with an approved targeted therapy.
  • Patient with active brain metastases who are not eligible for immediate local therapy, as per investigator evaluation.

Additional inclusion criteria for Phase Ib - Cohort 5 only

  • Non-squamous NSCLC patients with documented HER2 mutation in the TKD as per local lab results.
  • Patient should have received, in the advanced/metastatic setting, at least one line of systemic therapy that includes a platinum-based combination chemotherapy and should have been treated with previous HER2 directed antibody-drug conjugates (ADC) in the same advanced/metastatic setting and developed disease progression recurrence during or after completing this therapy. Patients with NSCLC harboring additional genomic aberrations for which approved targeted therapy is available as standard of care, must have received prior treatment with an approved targeted therapy.

Additional inclusion criteria for Phase Ib - Cohort 6 only

  • Non-squamous NSCLC patient with documented HER2 mutation in the TKD as per local lab results.
  • Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy.
  • Patient without active brain metastases or patient with active brain metastases who are not eligible for immediate local therapy, as per investigator evaluation.
  • Patient who is not eligible for any other recruiting cohort.

Additional inclusion criteria for Phase Ib - Cohort 7 only

  • Non-squamous NSCLC patient with documented HER2 mutation in the TKD as per local lab results.
  • Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy.
  • Patient without active brain metastases or patient with active brain metastases who are not eligible for immediate local therapy, as per investigator evaluation.
  • Patient who is not eligible for any other recruiting cohort.

Additional inclusion criteria for Phase Ib - Cohort 8 only

  • Treatment naïve for NSCLC
  • NSCLC (adenocarcinoma or squamous) patient with documented HER2 mutation in the tyrosine kinase domain (TKD) or non-squamous NSCLC with a documented HER2 mutation in the non tyrosine kinase domain (non TKD) as per local lab results

Additional inclusion criteria for Phase Ib - Cohort 9 only

  • Non-squamous NSCLC patient with documented HER2 mutation in the TKD as per local lab results.
  • Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy. Patients with NSCLC harboring additionally genomic aberrations for which approved targeted therapy is available as standard of care, must have received prior treatment with an approved targeted therapy.

Further inclusion criteria apply.

Exclusion Criteria:

  • Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to first trial treatment or planned within 6 months after screening

  • Previous or concomitant malignancies other than the one treated in this trial within the last 2 years, except:

    • effectively treated non-melanoma skin cancers
    • effectively treated carcinoma in situ of the cervix
    • effectively treated ductal carcinoma in situ
    • other effectively treated malignancy that is considered cured by local treatment.

  • Treatment with a systemic anti-cancer therapy or investigational drug within 21 days or 5 half-lives (whichever is shorter) of the first treatment with the study medication

  • Patients who must or wish to continue the intake of restricted medication or any drug considered likely to interfere with the safe conduct of the trial

  • Previous treatment with zongertinib.

  • Radiotherapy within 2 weeks prior to first study treatment, except palliative radiotherapy to regions other than the chest, which is allowed up to 1 week prior to first study treatment.

Further exclusion criteria apply.

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：顺序分配
  • 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：Ib 期 - 剂量扩展部分：队列 1
药品：zongertinib

zongertinib

其他名称：
  • BI 1810631，Hernexeos®
实验性的：Ib 期 - 剂量扩展部分：队列 2
药品：zongertinib

zongertinib

其他名称：
  • BI 1810631，Hernexeos®
实验性的：Ib 期 - 剂量扩展部分：队列 3
药品：zongertinib

zongertinib

其他名称：
  • BI 1810631，Hernexeos®
实验性的：Ib 期 - 剂量扩展部分：队列 4
药品：zongertinib

zongertinib

其他名称：
  • BI 1810631，Hernexeos®
实验性的：Ib 期 - 剂量扩展部分：队列 5
药品：zongertinib

zongertinib

其他名称：
  • BI 1810631，Hernexeos®
实验性的：Phase Ia - Dose escalation part

Consecutive cohorts of patients treated with escalating doses of BI 1810631 monotherapy.
药品：zongertinib

zongertinib

其他名称：
  • BI 1810631，Hernexeos®
实验性的：Phase Ib - Dose expansion part: Cohort 6

Cohort only in the United States of America (USA)
药品：zongertinib

zongertinib

其他名称：
  • BI 1810631，Hernexeos®
实验性的：Phase Ib - Dose expansion part: Cohort 7

Cohort only in Japan
药品：zongertinib

zongertinib

其他名称：
  • BI 1810631，Hernexeos®
实验性的：Phase Ib - Dose expansion part: Cohort 8

Cohort only in the United States of America (USA)
药品：zongertinib

zongertinib

其他名称：
  • BI 1810631，Hernexeos®
实验性的：Phase Ib - Dose expansion part: Cohort 9

Cohort only in China
药品：zongertinib

zongertinib

其他名称：
  • BI 1810631，Hernexeos®

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
Ia 期：MTD 评估期间出现剂量限制性毒性 (DLT) 的患者人数
大体时间：在第 1 周期结束时（每个周期为 21 天）。
在第 1 周期结束时（每个周期为 21 天）。
Ib 期：队列 4：根据中央独立审查的脑转移神经肿瘤学反应评估 (RANO-BM) 的客观反应
大体时间：从试验治疗开始到第 12 个月结束，最多 12 个月。
从试验治疗开始到第 12 个月结束，最多 12 个月。
Phase Ia: Maximum Tolerated Dose (MTD)
大体时间：At the end of Cycle 1 (each cycle is 21 days).

Maximum tolerated dose is defined as the highest dose with less than 25% risk of the true Dose Limiting Toxicity (DLT) rate being equal to or above 33% during the MTD evaluation period in any studied regimen.
At the end of Cycle 1 (each cycle is 21 days).
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Objective response (OR) as assessed by central independent review
大体时间：From the start of the trial treatment until end of month 12, up to 12 months.

OR is defined as best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1, from the first treatment administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anticancer therapy, loss to follow-up or withdrawal of consent.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (patients prior to CTP v8.0), 6, 7, 8, and 9: Objective response according to RECIST 1.1 by investigator assessment
大体时间：From the start of the trial treatment until end of month 12, up to 12 months.

Clincal Trial Protocol version 8.0 = CTP v8.0
From the start of the trial treatment until end of month 12, up to 12 months.

次要结果测量

结果测量
措施说明
大体时间
Ia 期：在整个治疗期间经历 DLT 的患者数量
大体时间：从试验治疗开始到第 8 个月结束，最多 8 个月。
从试验治疗开始到第 8 个月结束，最多 8 个月。
Ib 期 - 队列 4：根据中央独立审查的 RANO-BM 的客观反应持续时间 (DoR)
大体时间：从试验治疗开始到第 12 个月结束，最多 12 个月。
从试验治疗开始到第 12 个月结束，最多 12 个月。
Ib 期 - 队列 4：中央独立审查根据 RANO-BM 进行的疾病控制 (DC)
大体时间：从试验治疗开始到第 12 个月结束，最多 12 个月。
从试验治疗开始到第 12 个月结束，最多 12 个月。
Ib 期 - 队列 4：根据中央独立审查评估的 RANO-BM 的无进展生存期 (PFS)
大体时间：从试验治疗开始到第 12 个月结束，最多 12 个月。
从试验治疗开始到第 12 个月结束，最多 12 个月。
Ib 期 - 队列 4：或根据中央独立审查的 RECIST 1.1
大体时间：从试验治疗开始到第 12 个月结束，最多 12 个月。
从试验治疗开始到第 12 个月结束，最多 12 个月。
Ib 期 - 队列 4：根据中央独立审查的 RECIST 1.1 的 OR 持续时间
大体时间：从试验治疗开始到第 12 个月结束，最多 12 个月。
从试验治疗开始到第 12 个月结束，最多 12 个月。
Ib 期 - 队列 4：根据中央独立审查的 RECIST 1.1 的 DC
大体时间：从试验治疗开始到第 12 个月结束，最多 12 个月。
从试验治疗开始到第 12 个月结束，最多 12 个月。
Ib 期 - 所有队列：在整个治疗期间经历 DLT 的患者数量
大体时间：从试验治疗开始到第 12 个月结束，最多 12 个月。
从试验治疗开始到第 12 个月结束，最多 12 个月。
Ib 阶段 - 所有队列：EORTC 核心生活质量问卷 (EORTC QLQ-C30) 身体功能领域评分从基线到第 5 周期第 1 天的变化
大体时间：基线和第 5 个周期的第 1 天（每个周期为 21 天）。
基线和第 5 个周期的第 1 天（每个周期为 21 天）。
Ib 期 - 所有队列：非小细胞肺癌症状评估问卷 (NSCLC-SAQ) 总分从基线到第 5 周期第 1 天的变化
大体时间：基线和第 5 个周期的第 1 天（每个周期为 21 天）。
基线和第 5 个周期的第 1 天（每个周期为 21 天）。
Ib 期 - 所有队列：EORTC 项目列表 46 (IL46) 评分中从基线更改为第 5 周期第 1 天
大体时间：基线和第 5 个周期的第 1 天（每个周期为 21 天）。
基线和第 5 个周期的第 1 天（每个周期为 21 天）。
Ia 期：血浆中 zongertinib 的最大测量浓度 (Cmax)
大体时间：第 1 周期的第 1 天和第 15 天（每个周期为 21 天）。
第 1 周期的第 1 天和第 15 天（每个周期为 21 天）。
Ia期：血浆中zongertinib的浓度-时间曲线下面积（AUC0-t2）
大体时间：第 1 周期的第 1 天和第 15 天（每个周期为 21 天）。
第 1 周期的第 1 天和第 15 天（每个周期为 21 天）。
Ib 期 - 所有队列：总生存期 (OS)，定义为从首次治疗开始到因任何原因死亡的时间
大体时间：从试验治疗开始到第12个月结束，最长12个月。
从试验治疗开始到第12个月结束，最长12个月。
IB阶段-4：根据中央独立审查的RECIST 1.1的PFS
大体时间：从试用治疗开始到第12个月底，最长12个月。
从试用治疗开始到第12个月底，最长12个月。
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Duration of objective response (DoR) according to RECIST 1.1
大体时间：From the start of the trial treatment until end of month 12, up to 12 months.

DoR is defined as the time from first documented complete response (CR) or partial response (PR) until the earliest of disease progression or death among patients with objective response as assessed by central independent review.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Disease control (DC)
大体时间：From the start of the trial treatment until end of month 12, up to 12 months.

DC is defined as best overall response of complete response (CR) or partial response (PR) or stable disease (SD) where best overall response is defined according to RECIST version 1.1 as assessed central independent review, from first treatment administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up or withdrawal of consent.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Progression-free survival (PFS)
大体时间：From the start of the trial treatment until end of month 12, up to 12 months.

PFS is defined as the time from first treatment administration until tumor progression according to RECIST version 1.1 as assessed by central independent review, or death from any cause, whichever occurs earlier.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Objective response according to response assessment in RANO-BM criteria as assessed by central independent review for patients with central nervous system (CNS) lesions at baseline
大体时间：From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Disease control according to RANO-BM criteria as assessed by central independent review for patients with CNS lesions at baseline
大体时间：From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Objective response in CNS lesions according to RECIST 1.1 criteria as assessed by central independent review for patients with CNS lesions at baseline
大体时间：From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Disease control in CNS lesions according to RECIST 1.1 criteria as assessed by central independent review for patients with CNS lesions at baseline
大体时间：From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Duration of objective response according to RECIST 1.1 by investigator assessment
大体时间：From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Disease control according to RECIST 1.1 as assessed by the investigator
大体时间：From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Progression-free survival according to RECIST 1.1 as assessed by the investigator
大体时间：From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Objective response according to RANO-BM criteria as assessed by the investigator for patients with CNS lesions at baseline
大体时间：From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohorts 3 (enrolled before CTP v8.0), 6, 7, 8 and 9: Disease control according to RANO-BM criteria as assessed by the investigator for patients with CNS lesions at baseline
大体时间：From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: DoR in CNS lesions according to RECIST 1.1 by central independent review
大体时间：From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: DC in CNS lesions according to RECIST 1.1 by central independent review
大体时间：From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 months.
Phase Ib - Cohort 4: PFS in CNS lesions according to RECIST 1.1 as assessed by central independent review
大体时间：From the start of the trial treatment until end of month 12, up to 12 months.
From the start of the trial treatment until end of month 12, up to 12 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

Boehringer Ingelheim

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

有用的网址

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)

2021年7月2日

初级完成 (估计的)

2028年2月29日

研究完成 (估计的)

2029年8月29日

研究注册日期

首次提交

2021年5月4日

首先提交符合 QC 标准的

2021年5月12日

首次发布 (实际的)

2021年5月14日

研究记录更新

最后更新发布 (实际的)

2026年10月28日

上次提交的符合 QC 标准的更新

2026年10月27日

最后验证

2026年10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

  • 1479-0001
  • 2020-004563-47 (EudraCT编号)
  • 2024-511246-39-00 (注册表标识符：CTIS (EU))
  • U1111-1312-5969 (注册表标识符：WHO International Clinical Trials Registry Platform (ICTRP))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

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

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.

订阅