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Igg-Like T Cell Engager Binding To Dll3 And Cd3

This article discusses the ongoing clinical trial of BI 764532, an innovative IgG-like T cell engager that targets DLL3 and CD3. The drug is being studied for its potential in treating relapsed or refractory small cell lung cancer (SCLC) and other neuroendocrine carcinomas. The DAREON™-5 trial aims to evaluate the safety and efficacy of this promising therapy in patients who have progressed after standard treatments.

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What is IGG-Like T Cell Engager Binding to DLL3 and CD3?

IGG-Like T Cell Engager Binding to DLL3 and CD3, also known as BI 764532, is a new experimental drug being studied for the treatment of certain types of cancer[1]. This medication is classified as a T cell engager, which is a type of immunotherapy that helps your body’s immune system fight cancer cells.

Target Conditions

BI 764532 is being investigated for the treatment of several types of cancer, including:

  • Small Cell Lung Cancer (SCLC): A fast-growing type of lung cancer that usually spreads quickly[1].
  • Extra-pulmonary Neuroendocrine Carcinoma (epNEC): A rare type of cancer that starts in neuroendocrine cells outside the lungs[1].
  • Large Cell Neuroendocrine Carcinoma (LCNEC) of the lung: A rare and aggressive type of lung cancer[1].

These cancers are part of a group called neuroendocrine carcinomas, which are tumors that form from cells that release hormones into the blood in response to signals from the nervous system[1].

How the Drug Works

BI 764532 is designed to work in a unique way:

  1. It targets a protein called DLL3 (Delta-like ligand 3), which is found on the surface of certain cancer cells.
  2. It also binds to CD3, a protein found on T cells (a type of immune cell that fights infections and cancer).
  3. By binding to both DLL3 and CD3, the drug acts like a bridge, bringing cancer cells and T cells close together.
  4. This closeness allows the T cells to recognize and attack the cancer cells more effectively.

This approach is called T cell engagement, and it’s a promising new strategy in cancer treatment[1].

Clinical Trial Details

The drug is currently being studied in a clinical trial called DAREON™-5[1]. Here are some key details about the trial:

  • It’s a Phase II trial, which means it’s testing how well the drug works and checking its safety in a larger group of patients.
  • The trial is open-label, meaning both doctors and patients know which treatment is being given.
  • It’s testing different doses of BI 764532 to find out which one works best.
  • The drug is given through an intravenous infusion, which means it’s delivered directly into the bloodstream through a vein[1].

Eligibility Criteria

To participate in this trial, patients must meet certain criteria. Some key points include:

  • Patients must be 18 years or older.
  • They must have one of the cancers mentioned earlier (SCLC, epNEC, or LCNEC of the lung).
  • For SCLC patients, the cancer must have returned or gotten worse after at least two previous treatments, including one with platinum-based chemotherapy.
  • For epNEC or LCNEC patients, the cancer must have returned or gotten worse after at least one platinum-based chemotherapy treatment.
  • Patients must be in relatively good overall health, with an ECOG score (a measure of a person’s ability to perform daily activities) of 0 or 1[1].

There are also several conditions that would prevent a person from participating in the trial, such as certain other cancers, active infections, or specific medical conditions[1].

Potential Benefits

While it’s important to remember that BI 764532 is still experimental, researchers hope it might offer several benefits:

  • It may help shrink tumors or slow their growth in patients whose cancer has returned or gotten worse after other treatments.
  • It might provide a new treatment option for patients with limited choices.
  • The trial is also looking at how the drug affects patients’ quality of life, including their ability to perform daily activities[1].

Safety Considerations

As with any new treatment, safety is a top priority. The trial is closely monitoring for side effects, including:

  • Treatment-emergent adverse events (TEAEs): These are any new medical problems or worsening of existing problems that occur during treatment.
  • Immune-related side effects: Since the drug works with the immune system, it could potentially cause the immune system to attack healthy cells.
  • Infusion-related reactions: These are side effects that can occur during or shortly after receiving the drug through IV[1].

Patients in the trial will be closely monitored for these and other potential side effects. It’s important to note that the full range of possible side effects may not be known yet, as this is still an experimental treatment.

Aspect Details
Drug Name BI 764532
Drug Type IgG-like T cell engager binding to DLL3 and CD3
Trial Name DAREON™-5
Trial Phase Phase II
Target Conditions Relapsed/refractory small cell lung cancer, other neuroendocrine carcinomas
Primary Objectives Evaluate safety and efficacy of two dose levels
Administration Intravenous infusion
Treatment Duration 21-day cycles until disease progression or other termination reason
Key Eligibility Adults ≥18 years, confirmed SCLC or neuroendocrine carcinoma, prior platinum-based therapy
Primary Endpoints Objective response rate, treatment-emergent adverse events

FAQ

  • What is BI 764532 and how does it work? BI 764532 is an IgG-like T cell engager that binds to DLL3 and CD3. It's designed to activate T cells to target cancer cells expressing DLL3, which is commonly found in small cell lung cancer and other neuroendocrine carcinomas.
  • Who is eligible for this clinical trial? The trial is open to adults 18 years or older with confirmed SCLC who have progressed after at least two prior lines of therapy, including a platinum-based regimen. Patients with other advanced or metastatic neuroendocrine carcinomas who have progressed after at least one platinum-based regimen are also eligible.
  • What are the main objectives of the DAREON™-5 trial? The primary objectives are to evaluate the safety and efficacy of two dose levels of BI 764532 monotherapy in eligible patients. Secondary objectives include assessing duration of response, disease control, progression-free survival, overall survival, and patient-reported outcomes.
  • How is the drug administered in this trial? BI 764532 is administered as an intravenous infusion. The treatment is given in cycles of 21 days until disease progression or until another reason requires termination of treatment.
  • What are some of the key exclusion criteria for this trial? Key exclusion criteria include untreated or symptomatic brain metastases, active infections, certain hepatitis virus infections, leptomeningeal disease, active/previous history of interstitial lung disease, and previous treatment with DLL3-targeting T cell engagers or cell therapies.

Ongoing Clinical Trials on Igg-Like T Cell Engager Binding To Dll3 And Cd3

  • Study on BI 764532 for Patients with Relapsed or Refractory Small Cell Lung Cancer and Other Neuroendocrine Carcinomas

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria France Germany Italy Poland +2

  • Obrixtamig, Carboplatin, and Etoposide for First-Line Treatment of Advanced Extrapulmonary Neuroendocrine Carcinoma in DLL3-Positive Patients

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +8

  • A Study of BI 764532, Atezolizumab, Carboplatin, and Etoposide in Patients With Extensive-Stage Small Cell Lung Cancer

    Not yet recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Bulgaria Czechia Estonia Finland +14

Glossary

  • DLL3: Delta-like ligand 3, a protein expressed on the surface of certain cancer cells, particularly in small cell lung cancer and neuroendocrine tumors.
  • CD3: A protein complex found on the surface of T cells, which plays a role in activating T cells as part of the immune response.
  • T cell engager: A type of immunotherapy that helps direct T cells (a type of immune cell) to recognize and attack cancer cells.
  • Small cell lung cancer (SCLC): An aggressive type of lung cancer that tends to grow and spread quickly.
  • Neuroendocrine carcinoma: A type of cancer that begins in cells of the neuroendocrine system, which is made up of cells that are a combination of hormone-producing endocrine cells and nerve cells.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with the disease but it does not get worse.
  • Overall survival (OS): The length of time from the start of treatment or diagnosis that patients diagnosed with the disease are still alive.
  • ECOG score: Eastern Cooperative Oncology Group performance status, a scale used to assess how a patient's disease is progressing and how it affects daily living abilities.
  • Platinum-based regimen: A type of chemotherapy treatment that includes a platinum drug, such as cisplatin or carboplatin.

References

  1. http://clinicaltrials.eu/trial/study-on-bi-764532-for-patients-with-relapsed-or-refractory-small-cell-lung-cancer-and-other-neuroendocrine-carcinomas/