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A Study to Test Obrixtamig Treatment in People With Different Types of Advanced Cancer Who Took Part in a Previous Study With Obrixtamig

2026年11月5日 更新者：Boehringer Ingelheim

A Single-arm, Open-label, Safety Rollover Trial of Obrixtamig in Patients With Different Tumours

This study is open to adults with advanced cancer who received obrixtamig (BI 764532) in one of several previous studies and benefited from treatment. The goal of this study is to find out how well participants who received obrixtamig in a previous study tolerate obrixtamig. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer.

Participants in this study continue receiving obrixtamig and any other study or standard of care anti-cancer medicines they received in their previous study at the same doses and following the same treatment schedule. Treatments are given in 3-week cycles as infusions into a vein.

Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. During the visits, study doctors check participants' health and take note of any unwanted effects.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

68

阶段

  • 第三阶段

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

  • 德国
      • Dresden、德国、01307
      • Frankfurt、德国、60590
      • Würzburg、德国、97078
  • 日本
      • Saitama, Hidaka、日本、350-1298
        • Saitama Medical University International Medical Center
        • 接触：
      • Tokyo, Chuo-ku、日本、104-0045
        • National Cancer Center Hospital
        • 接触：
  • 比利时
      • Ghent、比利时、9000
  • 法国
      • Bordeaux、法国、33000
      • Bron、法国、69677
      • Paris、法国、75005
      • Strasbourg、法国、67091
      • Villejuif、法国、94805
  • 波兰
      • Gdansk、波兰、80-214
      • Lodz、波兰、93338
        • Polish Mother's Memorial Hospital - Research Institute
        • 接触：
  • 西班牙
      • Madrid、西班牙、28040
      • Madrid、西班牙、28034
        • Hospital Universitario Ramon Y Cajal
        • 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

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 :

  1. Patient is ongoing on obrixtamig treatment in any trial sponsored by Boehringer Ingelheim (hereafter referred to as the 'parent trial') that has achieved data cut-off for final analysis.
  2. Patient is benefiting from obrixtamig treatment according to investigators' assessment in the parent trial. Patients who experienced progressive disease in the parent trial will be eligible for the rollover trial, if treatment beyond progression has been agreed between the sponsor and investigators in the parent trial provided that patient is considered to derive clinical benefit.
  3. Patient meets the criteria for further obrixtamig treatment as defined in the clinical trial protocol of the parent trial they are currently participating in. Patients with ongoing dose delays due to adverse events in the parent trial are eligible, provided recovery from the adverse event takes place within the allowed time window in the parent trial.
  4. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF).
  5. Further inclusion criteria apply.

Exclusion criteria :

  1. Any medical condition which in the opinion of the investigator should exclude the patient from receiving treatment with obrixtamig.
  2. Participants who must receive or intend to receive restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
  3. Women who are pregnant, nursing, or who plan to become pregnant while participating in the trial.
  4. Patients who are institutionalized due to regulatory or juridical order; or dependent on sponsor, site or investigator.
  5. 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：不适用
  • 介入模型：单组作业
  • 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：Rollover arm

Patients who have previously received treatment with obrixtamig in another Boehringer Ingelheim-sponsored clinical trial (referred to as the 'parent trial') will be enrolled in this rollover study.

Treatment schedule and doses in the parent study will be continued in the rollover study.
生物：Obrixtamig

Obrixtamig

其他名称：
  • BI 764532
生物：Ezabenlimab

Ezabenlimab

生物：Atezolizumab

Atezolizumab

其他名称：
  • 技术中心
药品：Topotecan

Topotecan

生物：Tocilizumab

Tocilizumab

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Occurrence of treatment-emergent adverse events ( AEs) during the on-treatment period.
大体时间：Up to 36 months
Up to 36 months

次要结果测量

结果测量
大体时间
Obrixtamig treatment duration from the first administration in parent trial until the last administration in rollover trial.
大体时间：Up to 36 months
Up to 36 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。

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 (估计的)

2027年3月4日

初级完成 (估计的)

2028年7月3日

研究完成 (估计的)

2028年7月3日

研究注册日期

首次提交

2026年11月5日

首先提交符合 QC 标准的

2026年11月5日

首次发布 (实际的)

2026年11月10日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月5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

  • 1438-0038
  • 2026-527407-19-00 (注册表标识符：CTIS (EU))
  • U1111-1342-6504 (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

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

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.

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

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