BI 764532 for Small Cell Lung Cancer

Recruiting at 14 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Must not be taking: Anticoagulants, Immunosuppressants

Disqualifiers: Immunodeficiency, Active infection, Pregnancy, 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: 20

Duration: up to 36 months

282 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is open to adults with small cell lung cancer and other neuroendocrine cancers that are positive for the tumour marker delta-like 3 (DLL3). The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out the highest dose of BI 764532 and the best treatment schedule that people can tolerate. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. In this study, BI 764532 is given to people for the first time. That means no clinical data are available for BI 764532. Participants get BI 764532 either weekly or once every 3 weeks. If there is benefit for the participants and if they can tolerate it, the treatment is given for a maximum of 3 years. During this time, participants visit the study site about 20 times depending on the response to the treatment. 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 protocol does not specify if you must stop taking your current medications. However, you cannot participate if you are on certain treatments like systemic steroids or other anti-cancer drugs within a specific timeframe before starting the trial.

Eligibility Criteria

Adults with advanced small cell lung cancer or neuroendocrine tumors positive for DLL3, who have not had success with previous treatments or lack standard treatment options. Participants must be in good physical condition (ECOG 0-1), have at least one measurable tumor outside the brain, and their major organs must function well. Pregnant women, those on certain medications, or with other active cancers are excluded.

Inclusion Criteria

My cancer is advanced or has spread and cannot be cured with surgery or radiation.

I cannot use or have not responded to standard treatments.

I can't use standard cancer treatments or they didn't work for me.

Exclusion Criteria

I have not had major surgery within the last 4 weeks.

I have previously received treatments targeting DLL3.

I am not pregnant, nursing, or planning to become pregnant within 3 months after the trial ends.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BI 764532 either weekly or once every 3 weeks for a maximum of 3 years

up to 36 months

Approximately 20 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BI 764532

Trial Overview The trial is testing BI 764532, a new antibody-like molecule designed to help the immune system fight cancer. It's given either weekly or every three weeks for up to three years if tolerated and beneficial. The goal is to determine the highest tolerable dose and best treatment schedule.

Participant Groups

Group I: Arm 2: BI 764532 Experimental Treatment 1 Intervention

Group II: Arm 1: BI 764532 Experimental Treatment 1 Intervention

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+