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

NCT05916313 | Active Not Recruiting Phase 1 FDA Drug

• 3 other identifiers: 1438-0003U1111-1290-72342022-501766-22-01
• Study Type: interventional
• Target: 18
• Locations: 6 countries
• Sites: 12

Brief 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

Glioma

Outcome Measures

Primary Outcomes (1)

• Occurrence of dose-limiting toxicity (DLT) during the maximum tolerated dose (MTD) evaluation period

  up to 4 weeks

Secondary Outcomes (1)

• Occurrence of dose-limiting toxicity (DLT) during the entire treatment period

  up to 26 months

Study Arms (1)

BI 764532, dose escalation cohort

EXPERIMENTAL

Drug: BI 764532

Interventions

BI 764532 DRUG

BI 764532

Also known as: Obrixtamig

BI 764532, dose escalation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• Patients with histologically confirmed primary progressive diffuse glioma who have failed standard of care therapies.
• Availability of archival tumour tissue for Delta-like 3 (DLL3) expression by central assessment.
• Tumours must be positive for DLL3 expression by immunohistochemistry (IHC) on archived tumour tissue according to central pathology review.
• Documented unequivocal progression after radiotherapy and/or chemotherapy with measurable disease by response assessment in neuro-oncology (RANO) criteria.

You may not qualify if:

• Previous treatment in this trial.
• Current enrolment in another investigational device or drug trial.
• Presence of extracranial metastatic or leptomeningeal disease.
• Previous treatment with therapies targeting DLL3.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (12)

University of California Irvine

Orange, California, 92868, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

Salzburg Cancer Research Institute

Salzburg, 5020, Austria

Location

Universitätsklinikum Frankfurt

Frankfurt, 60596, Germany

Location

Klinikum der Universität München AÖR

München, 81377, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Erasmus Medisch Centrum-ROTTERDAM-50697

Rotterdam, 3015 GD, Netherlands

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Cantonal Hospital of Aarau

Aarau, CH-5001, Switzerland

Location

University Hospital of Lausanne

Lausanne, 1101, Switzerland

Location

University Hosp. Zurich

Zurich, 8901, Switzerland

Location

Related Links

• Related Info

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 23, 2023
• Study Start: January 30, 2024
• Primary Completion (Estimated): May 23, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); CH (3); US (2); DE (3); ES (2); AU (1)