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New antibody drug takes aim at Hard-to-Treat brain cancers

NCT ID NCT05916313

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This early-stage trial tests a new drug called BI 764532 in 20 adults with a type of brain tumor (glioma) that has a specific marker called DLL3 and hasn't improved with prior treatment. The drug is designed to link cancer cells to immune cells, helping the body fight the tumor. The main goal is to find a safe dose and see if it can be tolerated.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BI 764532 (Obrixtamig), an antibody-like molecule that links cancer cells and immune T-cells
What this could lead to
If it works, this could point toward a new treatment option for people with advanced glioma that hasn't responded to other therapies.
What could go wrong
This is an early, small Phase 1 trial focused on safety and dosing, not yet on effectiveness. The drug may not shrink tumors or may cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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 first informed consent form (ICF1). 2. Signed and dated written informed consent (ICF1 and ICF2) in accordance with International Council for Harmonisation-Good clinical practice (ICH-GCP) and local legislation prior to admission to the trial. 3. Patients with histologically confirmed primary progressive diffuse glioma who have failed standard of care therapies. 4. Availability of archival tumour tissue for Delta-like 3 (DLL3) expression by central assessment. 5. Tumours must be positive for DLL3 expression by immunohistochemistry (IHC) on archived tumour tissue according to central pathology review. 6. Documented unequivocal progression after radiotherapy and/or chemotherapy with measurable disease by response assessment in neuro-oncology (RANO) criteria. 7. Karnofsky performance score ≥70. Further inclusion criteria apply. Exclusion Criteria: 1. Previous treatment in this trial. 2. Current enrolment in another investigational device or drug trial. 3. Presence of extracranial metastatic or leptomeningeal disease. 4. Previous treatment with therapies targeting DLL3. 5. Prior treatment with bevacizumab or other anti-vascular endothelial growth factor (anti-VEGF) or anti-angiogenic treatment within 6 months prior to first administration of BI 764532. 6. Recent anti-cancer therapy: treatment with any other anticancer drug within 21 days or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532. 7. Radiotherapy within the 3 months prior to the diagnosis of progression; unless tumour progression is clearly outside the radiation field or tumour progression is unequivocally proven by surgery/biopsy. Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

glioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GLIOMA

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cantonal Hospital of Aarau

    RECRUITING

    Aarau, CH-5001, Switzerland

  • Erasmus Medisch Centrum-ROTTERDAM-50697

    RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital del Mar

    RECRUITING

    Barcelona, 08003, Spain

  • Klinikum der Universität München AÖR

    COMPLETED

    München, 81377, Germany

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Salzburg Cancer Research Institute

    RECRUITING

    Salzburg, 5020, Austria

  • University Hosp. Zurich

    RECRUITING

    Zurich, 8901, Switzerland

  • University Hospital of Lausanne

    RECRUITING

    Lausanne, 1101, Switzerland

  • University of California Irvine

    RECRUITING

    Orange, California, 92868, United States

  • Universitätsklinikum Frankfurt

    RECRUITING

    Frankfurt, 60596, Germany

  • Universitätsklinikum Tübingen

    RECRUITING

    Tübingen, 72076, Germany

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