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。

A Study in People With Advanced Cancer to Test How Well Different Doses of BI 3819026 Are Tolerated When Taken Alone and Together With Ezabenlimab

2026年8月3日 更新者：Boehringer Ingelheim

A First-in-human Phase I, Open-label, Multicentre, Dose Escalation Trial of BI 3819026 in Combination With Ezabenlimab in Patients With Unresectable Advanced or Metastatic Solid Cancers to Determine the Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE)

This study is open to adults with advanced cancer. The purpose of this study is to find the highest dose of BI 3819026 that people with advanced cancer can tolerate when taken alone and together with ezabenlimab. BI 3819026 and ezabenlimab are study medicines that may fight cancer.

Participants first receive one treatment of BI 3819026 alone, followed by treatment with a combination of BI 3819026 and ezabenlimab. Different doses of BI3819026 are given to small groups of participants, starting with the lowest dose. Treatment with the next higher dose of BI 3819026 starts only if the previous dose was tolerated. Each participant remains on the same dose of BI 3819026 throughout the study.

Participants are in the study for up to 2 years as long as they can tolerate the treatment and their condition does not get worse. During this time, they visit the study site regularly. The doctors look at the occurrence of certain health problems. They also regularly take blood samples, image participants' tumours, and take note of any unwanted effects.

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)

60

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

学习地点

  • 日本
      • Chiba, Kashiwa、日本、277-8577
        • 招聘中
        • National Cancer Center Hospital East
        • 接触：
      • Tokyo, Chuo-ku、日本、104-0045
        • 招聘中
        • National Cancer Center Hospital
        • 接触：
  • 美国
    • Connecticut
      • New Haven、Connecticut、美国、06511
    • New Jersey
      • Hackensack、New Jersey、美国、07601
    • New York
      • New York、New York、美国、10016
        • 尚未招聘
        • New York University Langone Medical Center
        • 接触：
    • Tennessee
      • Nashville、Tennessee、美国、37203
  • 西班牙
      • Barcelona、西班牙、08035
        • 招聘中
        • Hospital Universitari Vall d'Hebron
        • 接触：
      • Pamplona、西班牙、31008
        • 招聘中
        • Clinica Universidad de Navarra
        • 接触：
      • Valencia、西班牙、46010
        • 招聘中
        • Hospital Clínico Universitario de Valencia
        • 接触：

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria :

  1. Participants with histologically confirmed unresectable advanced or metastatic solid tumours who have documented progression after or are refractory to or ineligible for established and available therapies with proven clinical benefit, or have declined such therapy.
  2. At least one measurable disease lesion outside of the central nervous system (CNS) defined per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

  3. Patients with brain metastases are eligible provided they meet the following criteria:

    • Brain metastases have adequately been treated and are without progression or haemorrhage and are considered stable and asymptomatic by the investigator,
    • Radiotherapy and/or surgery for brain metastases was completed at least 14 and 28 days, respectively, prior to the first administration of BI 3819026,
    • Patient is off steroids and anti-convulsive drugs for at least 7 days prior to the first administration of BI 3819026 and has no requirement for such therapy at the time of initiating trial treatment.
  4. Availability of archived formalin-fixed and paraffin embedded (FFPE) tumour tissue. Patients who do not have archived FFPE tumour tissue available may be allowed to enrol without archival tumour tissue upon agreement between the investigator and the Sponsor
  5. All toxicities related to previous anti-cancer therapies have resolved to Grade ≤1 or baseline prior to trial treatment administration (except for alopecia, peripheral neuropathy and endocrinopathies considered irreversible [like hypothyroidism], and amenorrhea/menstrual disorders which can be any grade)
  6. Adequate liver, bone marrow and renal organ function Further inclusion criteria apply.

Exclusion Criteria :

  1. Previous or concomitant malignancies other than the one treated in this trial within the last 3 years except:

    • Effectively treated non-melanoma skin cancers
    • Effectively treated carcinoma in situ of the cervix
    • Effectively treated ductal carcinoma in situ of the breast
    • Other effectively treated malignancy that is considered cured by local treatment
  2. Has received prior therapy with an immune-checkpoint inhibitor that was discontinued due to immune-related adverse events (AE)
  3. Prior treatment with systemic anti-cancer drugs (including any agents or investigational medicinal products) within 3 weeks or 5 half-lives (whichever is shorter) before the first dose of trial treatment

  4. Radiotherapy within 4 weeks prior to start of the trial treatment except as follows:

    • Palliative radiotherapy to regions other than the chest is allowed if completed at least 2 weeks prior and is not on the target lesion (which should be outside of the radiation field)
    • Single dose palliative radiotherapy for symptomatic metastasis that is not the target lesion (which should be outside of the radiation field) within 2 weeks prior may be allowed
  5. Active/previous history of interstitial lung disease, pulmonary fibrosis, organising pneumonia or non-infectious pneumonitis (any grade)
  6. Patients with active autoimmune disease or a documented history of autoimmune disease, that requires systemic treatment, e.g. corticosteroids or immunosuppressive drugs, except patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy; patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible
  7. Patient has a diagnosis of immunodeficiency other than human immunodeficiency virus (HIV)

  8. Patients with history of HIV infection who meet one or more of the following criteria:

    • CD4+ count <350 cells/µL
    • Viral load >400 copies/mL
    • Not receiving antiretroviral therapy
    • Receiving established antiretroviral therapy for less than four weeks prior to the start of trial treatment
    • History of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months prior to start of trial treatment Patients with a history of HIV who do not meet any of the exclusion criteria above are eligible to participate but the patient must be under the care of an HIV/Infectious Diseases specialist, or an HIV/Infectious Diseases specialist must be consulted prior to inclusion 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：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：BI 3819026 + Ezabenlimab (BI 754091) dose group 1
Dose escalation
药品：BI 3819026
BI 3819026
药品：Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
实验性的：BI 3819026 + Ezabenlimab (BI 754091) dose group 2
Dose escalation
药品：BI 3819026
BI 3819026
药品：Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
实验性的：BI 3819026 + Ezabenlimab (BI 754091) dose group 3
Dose escalation
药品：BI 3819026
BI 3819026
药品：Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
实验性的：BI 3819026 + Ezabenlimab (BI 754091) dose group 4
Dose escalation
药品：BI 3819026
BI 3819026
药品：Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
实验性的：BI 3819026 + Ezabenlimab (BI 754091) dose group 5
Dose escalation
药品：BI 3819026
BI 3819026
药品：Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
实验性的：BI 3819026 + Ezabenlimab (BI 754091) dose group 3 backfill
药品：BI 3819026
BI 3819026
药品：Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
实验性的：BI 3819026 + Ezabenlimab (BI 754091) dose group 4 backfill
药品：BI 3819026
BI 3819026
药品：Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
实验性的：BI 3819026 + Ezabenlimab (BI 754091) dose group 5 backfill
药品：BI 3819026
BI 3819026
药品：Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Occurrence of dose-limiting toxicities (DLTs) in the primary DLT evaluation period
大体时间：Up to 30 days
Up to 30 days

次要结果测量

结果测量
措施说明
大体时间
Occurrence of adverse events (AEs) with onset during the on-treatment period
大体时间：Up to 2 years
Up to 2 years
Occurrence of DLTs with onset during the on-treatment period
大体时间：Up to 2 years
Up to 2 years
Occurrence of AEs with onset during Cycle 1
大体时间：Up to 15 days
Up to 15 days
Occurrence of DLTs with onset during Cycle 1
大体时间：Up to 15 days
Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 1
大体时间：Up to 15 days
Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 3
大体时间：Up to Day 30
Up to Day 30
Maximum measured concentration of BI 3819026 + ezabenlimab combination (C max) in cycle 3
大体时间：Up to Day 30
Up to Day 30
Area under concentration-time curve of BI 3819026 alone over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 1
大体时间：Up to 15 days
Up to 15 days
Area under concentration-time curve of BI 3819026 alone over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 3
大体时间：Up to Day 30
Up to Day 30
Area under concentration-time curve of BI 3819026 + ezabenlimab combination over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 3
大体时间：Up to Day 30
Up to Day 30
Treatment-induced changes in target cells as compared with baseline
大体时间：At baseline and up to 2 years
Backfill cohorts only: only patients in whom sequential biopsies are technically feasible and deemed safe by the investigator will be eligible
At baseline and up to 2 years
Treatment-induced changes in target cells ratio as compared with baseline
大体时间：At baseline and up to 2 years
Backfill cohorts only
At baseline and up to 2 years

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。

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)

2026年5月1日

初级完成 (估计的)

2028年6月5日

研究完成 (估计的)

2030年10月15日

研究注册日期

首次提交

2026年5月18日

首先提交符合 QC 标准的

2026年5月18日

首次发布 (实际的)

2026年5月26日

研究记录更新

最后更新发布 (实际的)

2026年8月4日

上次提交的符合 QC 标准的更新

2026年8月3日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2012-0001
  • 2025-522953-21-00 (注册表标识符：CTIS)
  • U1111-1328-0914 (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)？

是的

IPD 计划说明

Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD 共享时间框架

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD 共享访问标准

For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

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