BI 764532 for Small Cell Lung Cancer

Recruiting at 17 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

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the highest tolerable dose and best treatment schedule for a new treatment called BI 764532, which may help the immune system fight cancer. It targets adults with small cell lung cancer or other neuroendocrine cancers that express the DLL3 marker, particularly if previous treatments have failed or no standard options remain. Participants may receive the treatment weekly or every three weeks, for up to three years, depending on their response and tolerance. Ideal candidates have advanced cancer that tests positive for DLL3 and have exhausted other treatment options. 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 treatment.

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.

Is there any evidence suggesting that BI 764532 is likely to be safe for humans?

Research has shown that BI 764532 is generally safe based on early studies. Patients who received at least 90 micrograms per kilogram of the treatment tolerated it well. In some cases, this dosage even led to tumor shrinkage. Another study found that BI 764532 was safe and effective, with many patients responding well to the treatment. Although this is an early-stage study, these results suggest that the treatment is usually well-tolerated, with doctors closely monitoring for any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BI 764532 because it represents a novel approach to treating small cell lung cancer (SCLC). Unlike standard treatments such as chemotherapy and immunotherapy, which primarily target rapidly dividing cells or boost the immune response, BI 764532 works by specifically targeting a protein called Delta-like ligand 3 (DLL3). DLL3 is overexpressed in SCLC cells, making it a precise target, potentially leading to fewer side effects and more effective destruction of cancer cells. This targeted mechanism offers hope for better outcomes for patients with this aggressive form of lung cancer.

What evidence suggests that BI 764532 might be an effective treatment for small cell lung cancer?

Research has shown that BI 764532, a molecule similar to an antibody, might help treat small cell lung cancer by targeting a specific marker on tumors called delta-like 3 (DLL3). In lab studies with mice, this treatment made the tumors completely disappear. Early human studies found that doses of at least 90 micrograms per kilogram were safe and helped shrink tumors in some patients. The treatment activates T-cells, part of the immune system, to attack cancer cells. Although this study is in its early stages, these initial results suggest that BI 764532 could be effective against cancers with the DLL3 marker. Participants in this trial will receive BI 764532 as part of the study's experimental arms. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-00363

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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35815644/

Phase I trial of the DLL3/CD3 bispecific T-cell engager BI ... The bispecific DLL3/CD3 T-cell engager BI 764532 has been shown to induce complete tumor regression in a human T cell-engrafted mouse model.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04429087

NCT04429087 | A Study to Test Different Doses of BI ... 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).

4. aacrjournals.org aacrjournals.org/mct/article/22/12_Supplement/LB_A16/730466/Abstract-LB-A16-DareonTM-5-An-open-label-Phase-II

Dareon TM -5: An open-label Phase II trial of BI 764532, a ... BI 764532, a humanized IgG-like T cell engager, binds to DLL3-positive tumor cells and CD3 on T-cells and promotes T cell-mediated cytotoxicity.

5. onclive.com onclive.com/view/dose-optimization-continues-after-preliminary-efficacy-safety-signals-with-bi-764532-in-dll3-sclc

Dose Optimization Continues After Preliminary Efficacy ... Treatment with at least 90 μg/kg of the novel DLLC-targeting T-cell–engager BI 764532 was well tolerated and led to tumor shrinkage in patients ...

6. jto.org jto.org/article/S1556-0864(24)00933-X/fulltext

OA10.05 Phase I Trial of DLL3/CD3 IgG-Like T-Cell ... BI 764532 showed promising efficacy and safety in patients with LCNEC, with an ORR of 70% at active dose levels.