BI 764532 for Brain Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests BI 764532, a new treatment for brain tumors that display the DLL3 marker. The goal is to determine the highest dose safely administered to patients whose brain tumors have not responded to other treatments. BI 764532 connects cancer cells with the body's immune cells, potentially enabling the immune system to fight the cancer. People with DLL3-positive brain tumors who have not found success with previous treatments may be suitable candidates. Participants will receive the treatment intravenously and will visit the study site regularly to monitor their health and any side effects. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
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.
Is there any evidence suggesting that BI 764532 is likely to be safe for humans?
Research has shown that BI 764532 is generally safe for patients, based on previous studies. At doses that effectively treat cancer, the treatment's safety remains acceptable and manageable. While some side effects may occur, they are not too severe compared to the potential benefits. In these studies, doctors closely monitored patients to address any side effects promptly. This suggests that BI 764532 can be safely used when administered correctly.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for brain tumors, which typically involve surgery, radiation, and chemotherapy, BI 764532 is unique because it targets specific molecules that are overexpressed in tumor cells. This targeted approach aims to attack cancer cells more precisely, potentially sparing healthy cells and reducing side effects. Researchers are excited about BI 764532 because it represents a promising new way to fight brain tumors by focusing on the tumor's biology rather than using generalized toxic methods.
What evidence suggests that BI 764532 might be an effective treatment for brain tumors?
Research has shown that BI 764532, the investigational treatment in this trial, shows promise for brain tumors with the delta-like 3 (DLL3) marker. Early results indicate that this treatment can shrink tumors in 23% of patients. For certain cancers, such as small cell lung cancer (SCLC) and neuroendocrine carcinoma, BI 764532 halted disease progression in up to 100% of cases. This treatment aids the immune system's T-cells in connecting with cancer cells to combat the cancer. Initial findings suggest it is effective and well-tolerated by patients.13678
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BI 764532 infusions into a vein. Treatment continues if there is benefit and it is tolerated.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
BI 764532 is already approved in United States for the following indications:
- None approved; under investigation for extensive-stage small cell lung cancer (ES-SCLC) and extrapulmonary neuroendocrine carcinoma (epNEC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor
Citations
NCT05916313 | A Study to Test How Well Different Doses ...
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 ...
Phase I Dose-Escalation Results for the Delta-Like Ligand 3 ...
Across all doses, regimens, and tumor types, the overall response rate (ORR) was 23% (95% CI, 17.4% to 30.2%), the median duration of response ( ...
3.
onclive.com
onclive.com/view/bi-764532-shows-early-efficacy-manageable-tolerability-in-dll3-sclc-and-neuroendocrine-carcinomaBI 764532 Shows Early Efficacy, Manageable Tolerability ...
Additional efficacy findings showed that BI 764532 resulted in a DCR of 51% in those with SCLC, 44% in those with epNEC, and 100% in those with ...
A Study to Test How Well Different Doses of Obrixtamig (BI ...
A Study to Test How Well Different Doses of Obrixtamig (BI 764532) in Combination With Ezabenlimab Are Tolerated by People With Small Cell Lung Cancer and Other ...
NCT05916313 | A Study to Test How Well Different Doses ...
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 ...
Phase I Dose-Escalation Results for the Delta-Like Ligand ...
We report phase I results for obrixtamig (BI 764532), a delta-like ligand 3 (DLL3)/CD3 IgG-like T-cell engager, in patients with previously ...
Safety and efficacy outcomes of delta‑like ligand 3 ...
The median overall survival was 6.54 months and the median progression-free survival (PFS) was 3.54 months. Combination immunotherapy demonstrated a longer PFS ...
8.
cgtlive.com
cgtlive.com/view/novel-bispecific-t-cell-engager-bi-764532-manageable-tolerability-dll3-sclc-neuroendocrine-carcinomaNovel Bispecific T Cell Engager BI 764532 Shows ...
“At clinically efficacious BI 764532 dose levels, safety is clinically acceptable and manageable,” Wermke said in a presentation of the data.
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