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

Glioma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05916313
• Other study ID #: 1438-0003
• Secondary ID: U1111-1290-72342
• Status: Recruiting
• Phase: Phase 1
• Start date: December 13, 2023
• Est. completion date: August 17, 2026

Study information

• Verified date: May 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: August 17, 2026
• Est. primary completion date: August 17, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioma

Intervention

Drug:
• BI 764532
BI 764532

Locations

Country	Name	City	State
Austria	Salzburg Cancer Research Institute	Salzburg
Germany	Universitätsklinikum Frankfurt	Frankfurt am Main
Germany	Klinikum der Universität München AÖR	München
Germany	Universitätsklinikum Tübingen	Tübingen
Netherlands	Erasmus Medisch Centrum	Rotterdam
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Switzerland	Cantonal Hospital of Aarau	Aarau
Switzerland	University Hosp. Zurich, Dept. of Neurology, Stroke Center	Zurich
United States	SCRI Oncology Partners	Nashville	Tennessee
United States	University of California Irvine	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Netherlands,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Occurrence of dose-limiting toxicity (DLT) during the maximum tolerated dose (MTD) evaluation period		up to 4 weeks
Primary	Part B: Occurrence of dose-limiting toxicity (DLT) during the entire treatment period		up to 14 months
Secondary	Part A: Occurrence of dose-limiting toxicity (DLT) during the entire treatment period		up to 26 months

External Links

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