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Monoclonal Antibodies

BI 764532 for Brain Tumors

Phase 1
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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).
Patients with histologically confirmed primary progressive diffuse glioma who have failed standard of care therapies.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 26 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is for adults with a brain tumor that has a specific marker called delta-like 3 (DLL3). It is for people with advanced cancer who have not had success with previous treatments.The

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Specific side effects are not listed but will include any adverse reactions participants experience from infusions of BI 764532. These could range from mild infusion-related symptoms to more serious immune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 or older and meet my country's legal age for medical consent.
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My brain tumor has not responded to standard treatments.
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My tumor is DLL3 positive according to a special test.
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My cancer has grown despite treatment, as confirmed by specific tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 26 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 26 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part A: Occurrence of dose-limiting toxicity (DLT) during the maximum tolerated dose (MTD) evaluation period
Part B: Occurrence of dose-limiting toxicity (DLT) during the entire treatment period
Secondary study objectives
Part A: Occurrence of dose-limiting toxicity (DLT) during the entire treatment period

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: BI 764532: Part B - Dose expansion cohortExperimental Treatment1 Intervention
Group II: BI 764532: Part A - Dose escalation cohortExperimental Treatment1 Intervention

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Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,550 Previous Clinical Trials
15,769,258 Total Patients Enrolled
~22 spots leftby Aug 2026
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