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ACTIVE NOT RECRUITING
NCT05916313
PHASE1

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Official title: A Phase Ib Open-label, Multi-center, Dose Escalation Trial of BI 764532 Given as Monotherapy Administered by Repeated Intravenous Infusions in Patients With Glioma Expressing DLL3

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2024-01-30

Completion Date

2026-06-30

Last Updated

2026-03-17

Healthy Volunteers

No

Conditions

Interventions

DRUG

BI 764532

BI 764532

Locations (12)

University of California Irvine

Orange, California, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Salzburg Cancer Research Institute

Salzburg, Austria

Universitätsklinikum Frankfurt

Frankfurt, Germany

Klinikum der Universität München AÖR

München, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Erasmus Medisch Centrum-ROTTERDAM-50697

Rotterdam, Netherlands

Hospital del Mar

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Cantonal Hospital of Aarau

Aarau, Switzerland

University Hospital of Lausanne

Lausanne, Switzerland

University Hosp. Zurich

Zurich, Switzerland