BI 764532 for Small Cell Lung Cancer

Recruiting at 69 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Brain metastases, Pneumonitis, Immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

174 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to determine the optimal dose of a new treatment, BI 764532, that individuals with advanced small cell lung cancer or certain neuroendocrine tumors can tolerate. The trial tests whether BI 764532, an experimental treatment, can shrink tumors by enhancing the immune system. Participants receive one of two doses at random to identify the most effective option. Those who have tried other cancer treatments without success and have difficult-to-treat tumors might be suitable candidates. Participants receive the treatment through an IV and undergo regular health check-ups during the study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

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 have had any other anti-cancer drug within 4 weeks or within 5 half-life periods before starting the trial drug. You also need to be off steroids and anti-epileptic drugs for at least 7 days before starting the trial, unless they are at stable doses.

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

Research has shown that BI 764532 has potential based on earlier studies. This treatment aims to help the immune system fight cancer by targeting specific proteins on cancer cells. In a previous study, patients received at least 90 micrograms per kilogram of the treatment. Most tolerated this dose well, experiencing no severe side effects, and some even saw their tumors shrink.

Although the treatment remains under investigation, these early results are encouraging regarding its safety in humans. Researchers closely monitor participants, especially at the start of treatment, to quickly address any side effects. This careful monitoring helps them understand how people react to the treatment and ensures safety throughout the study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for small cell lung cancer?

Unlike the standard treatments for small cell lung cancer, which often include chemotherapy and immunotherapy, BI 764532 offers a novel approach by targeting a specific protein involved in cancer cell growth. This drug is designed to interfere with the molecular pathways that support tumor survival, potentially leading to more effective cancer cell destruction. Researchers are excited about BI 764532 because it could provide a more targeted treatment option, possibly with fewer side effects compared to conventional therapies. By honing in on the unique biology of cancer cells, this treatment has the potential to improve outcomes for patients with small cell 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 treatment tested for small cell lung cancer in this trial, has promising results in early studies. It targets a protein called DLL3, found on many cancer cells. By attaching to DLL3 and another protein on T-cells, BI 764532 helps the immune system attack the cancer. Specifically, early studies demonstrated that it can reduce tumor size in some patients. This suggests that BI 764532 might help shrink tumors in cases of small cell lung cancer. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

Adults with advanced small cell lung cancer or neuroendocrine tumors, who have had unsuccessful prior treatments or no standard treatment options. Participants must be over 18, have measurable lesions, provide consent, and agree to use effective birth control. They should not have severe allergies to immuno-oncology agents or certain lung conditions.

Inclusion Criteria

My cancer is primarily neuroendocrine or small cell lung cancer.

My small cell lung cancer has worsened after two treatments, including a platinum-based one.

All my side effects from past cancer treatments are mild, except for hair loss, nerve pain, or menstrual changes.

Exclusion Criteria

I haven't taken immunosuppressive drugs or steroids, except for replacement, in the last 7 days.

Unresolved toxicity from prior anti-tumour therapy, defined as per protocol

I had a severe reaction to immune therapy that stopped my treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants are randomly assigned to receive one of two doses of BI 764532 as an infusion. The first study visits include an overnight stay to monitor participants' safety.

up to 26 months

Regular visits with overnight stay initially

Treatment Part 2

All participants receive the same dose of BI 764532. This phase is open to people with extrapulmonary neuroendocrine carcinoma.

up to 27 months

Regular visits

Follow-up

Participants are monitored for safety and effectiveness after treatment. Doctors record any unwanted effects and regularly check the general health of the participants.

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 764532

Trial Overview The trial is testing two different doses of BI 764532, an experimental antibody-like molecule designed to help the immune system fight cancer. Patients are randomly assigned to receive one of the two doses via vein infusion and monitored for tumor response and tolerability.

How Is the Trial Designed?

Group I: Part 2: Expansion cohort Experimental Treatment 1 Intervention

Group II: Part 1: Dose group 2 Experimental Treatment 1 Intervention

Group III: Part 1: Dose group 1 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. 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).

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.8502

First-in-human dose-escalation trial of BI 764532, a delta- ... BI 764532 is a DLL3/CD3 T cell engaging bispecific antibody that has shown potent preclinical anti-tumor activity in DLL3+ cells and xenograft models.

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. asco.org asco.org/abstracts-presentations/ABSTRACT329025

A phase I, open-label, dose-escalation trial of BI 764532 ... BI 764532 is a delta-like ligand 3 (DLL3)/CD3 T cell engaging bispecific antibody. DLL3 is expressed on the cell surface of many SCLC and NEC tumors, but not ...

6. 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.

7. 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 ...