BI 764532 for Brain Tumors

Recruiting at 11 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Must not be taking: Anti-VEGF, Anti-angiogenic

Disqualifiers: Extracranial metastatic, Leptomeningeal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Variable, based on response and tolerance

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking any other anticancer drugs at least 21 days before starting the study treatment. If you are on such medications, you will need to stop them before participating.

Eligibility Criteria

Adults with a brain tumor positive for DLL3, who have not had success with standard treatments. They must be over 18 (or the legal age of consent), able to give written consent, and have a Karnofsky performance score of at least 70. Their tumors should show clear progression after prior therapies and be measurable by specific criteria.

Inclusion Criteria

I have signed all required consent forms for this trial.

My brain tumor has not responded to standard treatments.

My cancer tissue is available for DLL3 testing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BI 764532 infusions into a vein. Treatment continues if there is benefit and it is tolerated.

Variable, based on response and tolerance

Regular intervals, with initial visits including safety monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BI 764532

Trial Overview The trial is testing different doses of BI 764532 to find the highest amount patients can tolerate without severe side effects. BI 764532 is designed to help the immune system fight cancer by linking cancer cells and T-cells together.

Participant Groups

Group I: BI 764532: Part A - Dose escalation cohort Experimental Treatment 1 Intervention

Part B of the trial was removed via amendment/new protocol version from February 2025.

BI 764532 is already approved in United States for the following indications:

Approved in United States as BI 764532 for:

• None approved; under investigation for extensive-stage small cell lung cancer (ES-SCLC) and extrapulmonary neuroendocrine carcinoma (epNEC)

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+