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

Part of paid clinical trials in Orange, California.

Sponsor
Boehringer Ingelheim
Study ID
NCT05916313
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BI 764532 — DRUG
    BI 764532

Study Details

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.

Key Dates

First listed
Jun 23, 2023
Start date
Jan 30, 2024
Status verified
Aug 2026
Primary completion
Aug 9, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BI 764532, dose escalation cohort

Primary Outcome Measure

Occurrence of dose-limiting toxicity (DLT) during the maximum tolerated dose (MTD) evaluation period [ Time Frame: up to 4 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California IrvineOrangeCalifornia92868
Boehringer Ingelheim
[email protected]
833-602-2368
SCRI Oncology PartnersNashvilleTennessee37203
Boehringer Ingelheim
[email protected]
833-602-2368

Find similar trials in Orange, CA

Nationwide
Brain cancer trialsOncology trialsNeuro-oncology trials
By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of California Irvine· Orange, CASCRI Oncology Partners· Nashville, TN

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