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NCT05916313 · ClinicalTrials.gov registry record · Phase 1

A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With a Tumour in the Brain That is Positive for DLL3

A Phase 1 study of Glioma, sponsored by Boehringer Ingelheim.

Active
Registry status
Phase 1
Development phase
18
Enrollment target
12
Study locations

NCT05916313 is a Phase 1 study of Glioma that is active but no longer recruiting, run by Boehringer Ingelheim. The registered enrollment target is 18 participants, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (91% lower). The trial reports 12 study locations across 3 states.

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The verdict

NCT05916313, a Phase 1 study of Glioma, is active but no longer recruiting, sponsored by Boehringer Ingelheim.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
18 participants
Enrollment target
12
Study locations

Study Summary

This study (1438-0003) is open to adults with a tumour in the brain that is positive for the tumour marker delta-like 3 (DLL3). This study is in people with advanced cancer for whom previous treatment was not successful. The purpose of this study is to find out the highest dose of BI 764532 that people with a brain tumour that is positive for DLL3 can tolerate. BI 764532 is an antibody-like molecule that can attach and link together the cancer cells and T-cells of the immune system (DLL3/CD3 bispecific). This may help the immune system fight cancer. Participants get BI 764532 infusions into a vein when starting treatment. If there is benefit for the participants and if they can tolerate it, the treatment is continued. During this time, participants visit the study site at regular intervals. The total number of visits depends on how they respond to and tolerate the treatment. The first study visits include staying to monitor participants' safety. Doctors record any unwanted effects and regularly check the general health of the participants.

Conditions Studied

Interventions

  • DRUG BI 764532

Study Locations (12)

Other

  • Salzburg Cancer Research Institute - Salzburg
  • Universitätsklinikum Frankfurt - Frankfurt
  • Klinikum der Universität München AÖR - München
  • Universitätsklinikum Tübingen - Tübingen
  • Erasmus Medisch Centrum-ROTTERDAM-50697 - Rotterdam
  • Hospital del Mar - Barcelona
  • Hospital Universitario 12 de Octubre - Madrid
  • Cantonal Hospital of Aarau - Aarau
  • University Hospital of Lausanne - Lausanne
  • University Hosp. Zurich - Zurich

California

  • University of California Irvine - Orange

Tennessee

  • SCRI Oncology Partners - Nashville

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2024-01-30
Est. Completion 2026-06-30
Phase Phase 1

Sponsor

Boehringer Ingelheim

515 total trials

What the Registry Record Tells You About NCT05916313

The ClinicalTrials.gov registry entry for NCT05916313 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (91% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Glioma appearing as the primary indexed condition, and to 1 intervention - of which BI 764532 is the first listed.

NCT05916313 reports 12 study locations spanning 3 distinct geographic areas - top geographies include Other, California, Tennessee.

Frequently Asked Questions

What is clinical trial NCT05916313 about?

NCT05916313 is a clinical study titled "A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With a Tumour in the Brain That is Positive for DLL3". This study (1438-0003) is open to adults with a tumour in the brain that is positive for the tumour marker delta-like 3 (DLL3). This study is in people with advanced cancer for whom previous treatment was not successful. The purpose of this study is to find out the highest dose of BI 764532 that pe...

What is the current status of trial NCT05916313?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2024-01-30. Estimated completion is 2026-06-30.

What conditions does trial NCT05916313 study?

This clinical trial studies the following conditions: Glioma.

What interventions are being tested in trial NCT05916313?

The interventions under investigation include: BI 764532 (DRUG).

Who is sponsoring clinical trial NCT05916313?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05916313 being conducted?

This trial has 12 study locations across California, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.