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

Last updated: April 15, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Recruiting

Phase

1

Condition

Brain Cancer

Neurofibromatosis

Cancer

Treatment

BI 764532

Clinical Study ID

NCT05916313
1438-0003
U1111-1290-7234
2022-501766-22-01
2022-501766-22-00
2022-501766-22
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female participants ≥18 years old and at least at the legal age of consentin countries where it is greater than 18 years at the time of signature of the firstinformed consent form (ICF1).

  2. Signed and dated written informed consent (ICF1 and ICF2) in accordance withInternational Council for Harmonisation-Good clinical practice (ICH-GCP) and locallegislation prior to admission to the trial.

  3. Patients with histologically confirmed primary progressive diffuse glioma who havefailed standard of care therapies.

  4. Availability of archival tumour tissue for Delta-like 3 (DLL3) expression by centralassessment.

  5. Tumours must be positive for DLL3 expression by immunohistochemistry (IHC) onarchived tumour tissue according to central pathology review.

  6. Documented unequivocal progression after radiotherapy and/or chemotherapy withmeasurable disease by response assessment in neuro-oncology (RANO) criteria.

  7. Karnofsky performance score ≥70. Further inclusion criteria apply.

Exclusion

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 firstadministration of BI 764532.

  6. Recent anti-cancer therapy: treatment with any other anticancer drug within 21 daysor within 5 half-life periods (whichever is shorter) prior to first administrationof BI 764532.

  7. Radiotherapy within the 3 months prior to the diagnosis of progression; unlesstumour progression is clearly outside the radiation field or tumour progression isunequivocally proven by surgery/biopsy.

Further exclusion criteria apply.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: BI 764532
Phase: 1
Study Start date:
February 21, 2024
Estimated Completion Date:
March 30, 2026

Connect with a study center

  • Salzburg Cancer Research Institute

    Salzburg, 5020
    Austria

    Active - Recruiting

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60528
    Germany

    Active - Recruiting

  • Klinikum der Universität München AÖR

    München, 81377
    Germany

    Active - Recruiting

  • Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD
    Netherlands

    Active - Recruiting

  • Erasmus Medisch Centrum-ROTTERDAM-50697

    Rotterdam, 3015 GD
    Netherlands

    Active - Recruiting

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Cantonal Hospital of Aarau

    Aarau, CH-5001
    Switzerland

    Active - Recruiting

  • University Hospital of Lausanne

    Lausanne, 1101
    Switzerland

    Active - Recruiting

  • University Hosp. Zurich

    Zurich, 8901
    Switzerland

    Active - Recruiting

  • University Hosp. Zurich, Dept. of Neurology, Stroke Center

    Zurich, 8091
    Switzerland

    Site Not Available

  • University of California Irvine

    Orange, California 92868
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

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