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Monoclonal Antibodies

BI 764532: Part B - Dose expansion cohort for Brain Tumor

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 26 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Part A: Occurrence of dose-limiting toxicity (DLT) during the entire treatment period

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,507 Previous Clinical Trials

11,340,872 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the dose escalation cohort of BI 764532, also known as Part A, received approval from the FDA?

"Based on the assessment of our team at Power, the safety rating for BI 764532: Part A - Dose escalation cohort is determined to be a score of 1. This evaluation reflects the fact that this trial falls under Phase 1, where there exists limited data supporting both safety and efficacy."

Answered by AI

Are new patients currently being welcomed to participate in this ongoing clinical trial?

"Indeed, according to the information provided on clinicaltrials.gov, this trial is currently in the patient recruitment phase. The initial posting of the study occurred on December 13, 2023, and it was last edited on December 14, 2023."

Answered by AI

What is the total number of participants being recruited for this research endeavor?

"Indeed, as indicated on clinicaltrials.gov, this ongoing trial is currently seeking eligible patients. The initial posting was made on December 13th, 2023 and the most recent update occurred on December 14th, 2023. Recruitment aims to enroll a total of 35 participants from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05916313.

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