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一项在不同类型的晚期癌症（实体瘤）患者中单独测试不同剂量的 BI 1831169 以及与 Ezabenlimab 联合使用的研究

2026年10月26日 更新者：Boehringer Ingelheim

BI 1831169 单药治疗和与 Ezabenlimab 联合治疗晚期或转移性实体瘤患者的 I 期开放标签剂量递增试验

This study is open to adults with different types of advanced cancer (solid tumors) that are accessible for injection and/or biopsy. This is a study for people with a life expectancy of at least 3 months after starting study treatment. The purpose of this study is to find the highest dose of a medicine called BI 1831169 that people with advanced cancer can tolerate when taken with or without a type of antibody called a checkpoint inhibitor (anti-PD-1 antibody). Another purpose is to check whether the study treatment can fight cancer. In this study, BI 1831169 is given to people for the first time.

This study has 2 parts. In Part 1, participants get BI 1831169 alone for up to 3 months. In Part 2, participants get BI 1831169 in combination with a checkpoint inhibitor. Participants who take the combination treatment get BI 1831169 for up to 3 months and a checkpoint inhibitor for up to 1 year. BI 1831169 is given as an injection into the tumor, or as an infusion into the vein, or both (injection and infusion). Checkpoint inhibitors are given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle.

Participants visit the site study site regularly. The number of study visits vary based on the study phase and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors also take note of any health problems that could have been caused by the study treatment.

研究概览

地位

暂停

条件

干预/治疗

研究类型

介入性

注册 (估计的)

190

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。

学习地点

  • 加拿大
    • Ontario
      • Toronto、Ontario、加拿大、M5G 2M9
        • Princess Margaret Cancer Centre
  • 奥地利
      • Innsbruck、奥地利、6020
        • Medical University of Innsbruck
      • Salzburg、奥地利、5020
        • Salzburg Cancer Research Institute
  • 德国
      • Tübingen、德国、72076
        • Universitätsklinikum Tübingen
      • Ulm、德国、89081
        • Universitätsklinikum Ulm
  • 意大利
      • Milan、意大利、20162
        • ASST Grande Ospedale Metropolitano Niguarda
  • 比利时
      • Edegem、比利时、2650
        • Universitair Ziekenhuis Antwerpen
      • Leuven、比利时、3000
        • UZ Leuven
  • 法国
      • Bordeaux、法国、33000
        • INS Bergonie
      • Marseille、法国、13385
        • HOP Timone
      • Rennes、法国、35042
        • CTR Eugène Marquis
      • Villejuif、法国、94805
        • Institut Gustave Roussy
  • 澳大利亚
    • South Australia
      • Bedford Park、South Australia、澳大利亚、5062
        • Southern Oncology Clinical Research Unit
    • Victoria
      • Frankston、Victoria、澳大利亚、3199
        • Peninsula Haematology & Oncology
  • 瑞士
      • Geneva、瑞士、1205
        • University Hospital Geneva
  • 美国
    • Arizona
      • Gilbert、Arizona、美国、85234
        • Banner MD Anderson Cancer Center-Gilbert-55251
      • Tucson、Arizona、美国、85719
        • University of Arizona
    • California
      • La Jolla、California、美国、92037
        • University of California San Diego
      • Santa Monica、California、美国、90404
        • Providence St. John's Health Center
    • Colorado
      • Aurora、Colorado、美国、80045
        • University of Colorado Denver
    • Florida
      • Miami、Florida、美国、33136
        • University of Miami
      • Orlando、Florida、美国、32806
        • Orlando Health Cancer Institute
    • Georgia
      • Atlanta、Georgia、美国、30322
        • Winship Cancer Institute
    • Kentucky
      • Louisville、Kentucky、美国、40202
        • University of Louisville
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • M Health Fairview University of Minnesota Medical Center
    • New Jersey
      • Morristown、New Jersey、美国、07960
        • Morristown Medical Center
    • North Carolina
      • Winston-Salem、North Carolina、美国、27157
        • Atrium Health Wake Forest Baptist Comprehensive Cancer Center
    • South Carolina
      • Greenville、South Carolina、美国、29605
        • Prisma Health
    • Tennessee
      • Nashville、Tennessee、美国、37203
        • Tennessee Oncology, PLLC - Elliston Place Plaza DDU
    • Texas
      • Houston、Texas、美国、77030
        • The University of Texas MD Anderson Cancer Center
  • 西班牙
      • L'Hospitalet de Llobregat、西班牙、08907
        • Hospital Duran i Reynals
      • Madrid、西班牙、28040
        • Fundación Jiménez Díaz
      • Pamplona、西班牙、31008
        • Clínica Universidad de Navarra

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 advanced, unresectable and/or metastatic or relapsed/refractory solid tumors
  • At least one or two accessible lesions, one with a minimum lesion diameter for injection of BI 1831169 (where applicable), and one which is amenable to biopsy (where applicable). Lesions must either be easily accessible or, if not easily accessible, patient must be willing to undergo repeated procedures (e.g., image guided procedures) for both biopsies and injections of BI 1831169
  • Has failed conventional treatment or for whom no therapy of proven efficacy exists, who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease. This criterion does not apply to the specific indications in Part 2.

Further inclusion criteria apply.

Exclusion Criteria:

  • Previous treatment with Vesicular stomatitis virus (VSV)-based agents
  • Concomitant medication or condition considered a high risk for complications from injection or biopsy as per the Investigator's judgement
  • Presence of brain metastases
  • Presence of Human Immunodeficiency Virus (HIV) meeting certain criteria, active autoimmune disease or chronic active infection (Hepatitis C or B virus (HCV/HBV))
  • Chronic steroid use, regardless of daily dose 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：第 1 部分（单一疗法）：A 组
药品：BI 1831169

BI 1831169
实验性的：第 1 部分（单一疗法）：B 组
药品：BI 1831169

BI 1831169
实验性的：第 1 部分（单一疗法）：C 组
药品：BI 1831169

BI 1831169
实验性的：第 2 部分（联合治疗）：D 组
药品：BI 1831169

BI 1831169

药品：anti-PD-1 antibody

anti-PD-1 antibody
实验性的：第 2 部分（联合治疗）：E 组
药品：BI 1831169

BI 1831169

药品：anti-PD-1 antibody

anti-PD-1 antibody

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
Part 1.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the mono Maximum tolerated dose (MTD) evaluation period
大体时间：up to 21 days

Part 1 (Monotherapy).
up to 21 days
Part 1.2, Dose expansion: Objective response (OR) defined as best overall response (BOR) of confirmed intratumoral immunotherapy complete response (itCR) or confirmed intratumoral immunotherapy partial response (itPR)
大体时间：up to 49 months

BOR is defined according to Response Criteria for Intratumoral Immunotherapy in Solid Tumors (itRECIST).

BOR will consider all tumor assessments from first administration of trial medication until disease progression or death (whichever occurs first) or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.
up to 49 months
Part 2.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the combination Maximum tolerated dose (MTD) evaluation period
大体时间：up to 21 days

Part 2 (Combination Therapy).
up to 21 days
Part 2.2, Dose Expansion: Objective response (OR) defined as best overall response (BOR) of confirmed immunotherapy complete response (iCR) or confirmed partial response (iPR)
大体时间：up to 49 months

BOR is defined according to Response Criteria for Intratumoral Immunotherapy in Solid Tumors (itRECIST) by Investigator's assessment.

BOR will consider all tumor assessments from first administration of trial medication until disease progression, death, last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent (whichever occurs first).
up to 49 months

次要结果测量

结果测量
措施说明
大体时间
第 1.1 部分，剂量递增/确认：治疗期间 DLT 的发生
大体时间：长达 49 个月
长达 49 个月
第 1.1 部分，剂量递增/确认：治疗期间不良事件的发生
大体时间：长达 49 个月
长达 49 个月
第 1.2 部分，剂量扩展：治疗期间不良事件的发生
大体时间：长达 49 个月
长达 49 个月
第 1.2 部分，剂量扩展：单 MTD 评估期间 DLT 的发生
大体时间：长达 49 个月
长达 49 个月
第 2.1 部分，剂量递增/确认：治疗期间 DLT 的发生
大体时间：长达 49 个月
长达 49 个月
第 2.1 部分，剂量递增/确认：治疗期间不良事件的发生
大体时间：长达 49 个月
长达 49 个月
第 2.2 部分 - 按适应症扩大剂量，所有组：治疗期间不良事件的发生
大体时间：长达 49 个月
长达 49 个月
Part 2.2 - Dose Expansion by Indication, Arms D and E: Duration of objective response (DoR)
大体时间：up to 49 months

DoR is defined as the time from first documented iCR or iPR according to iRECIST until the earliest of disease progression by Investigator's assessment or death among patients with OR.
up to 49 months
Part 2.2, Dose Expansion by Indication, Arms D and E: Disease control (DC)
大体时间：up to 49 months

DC is defined as a BOR of iCR, iPR or immunotherapy stable disease (iSD), with BOR defined according to iRECIST by Investigator's assessment.
up to 49 months
Part 2.2, Dose Expansion by Indication, Arm E: Progression-Free Survival (PFS) rate at 4 months (PFS-4)
大体时间：up to 4 months

PFS-4 is defined as the proportion of patients who are alive and without progression by 4 months from the start of treatment. PFS is assessed by the Investigator using iRECIST.
up to 4 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)

2022年3月28日

初级完成 (估计的)

2027年12月13日

研究完成 (估计的)

2028年10月31日

研究注册日期

首次提交

2021年12月10日

首先提交符合 QC 标准的

2021年12月10日

首次发布 (实际的)

2021年12月13日

研究记录更新

最后更新发布 (实际的)

2026年10月27日

上次提交的符合 QC 标准的更新

2026年10月26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

  • 1456-0001
  • 2020-003902-30 (EudraCT编号)

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.

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