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A study to evaluate the safety and effectiveness of BNT324 and BNT327 in patients with advanced lung cancer

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals with Advanced Lung Cancer, which includes types such as Non-Small Cell Lung Cancer and Small Cell Lung Cancer. The research aims to investigate the efficacy and safety of a combination therapy using two experimental drugs, BNT324 and BNT327. These medications are administered through an intravenous infusion, which is a method of delivering fluids or medicine directly into a vein.

The study is divided into two parts to determine the best way to use these medicines. In the first part, different amounts of the drugs are given to find the safest and most effective dose. The second part focuses on finding the optimal dose and observing how well the combination works for different types of lung cancer. Throughout the process, the safety and how the body processes the drugs are closely monitored.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>participation in dose escalation</b>

    The first part of the study focuses on dose escalation. This step is used to find the recommended dose for the combination of two medicines, BNT324 and BNT327.

    The medicines, BNT324 and BNT327, are administered through intravenous infusion, which means they are delivered directly into a vein. During this stage, the focus is on monitoring safety and how well the body can tolerate the combination of these two medicines.

  2. Step 2

    <b>participation in dose optimization and efficacy evaluation</b>

    The second part of the study is divided into different groups to determine the optimal dose and to see how well the medicines work.

    In cohorts 1 and 2, the focus is on finding the best dose by assessing safety and how the medicines affect the cancer. This includes participants with non-small cell lung cancer who have not received prior treatment, and participants with small cell lung cancer whose cancer has returned or progressed.

    In cohorts 3 through 7, the study evaluates how well the BNT324 and BNT327 combination works by using specific response criteria to measure changes in the tumor size.

    Throughout these stages, safety is monitored by tracking any side effects or adverse events that occur from the time the first dose is given until 90 days after the last dose is administered, or until a different cancer treatment is started.

Who can join the trial?

8 criteria

  • You must be at least 18 years old when you agree to join the study.
  • You must have advanced or metastatic lung cancer, which means the cancer is in an advanced stage or has spread to other parts of the body, and it cannot be removed by surgery.
  • Your cancer type must be confirmed through histology (looking at tissue samples under a microscope) or cytology (looking at individual cells under a microscope).
  • If you have non-small cell lung cancer (NSCLC), you can participate regardless of your PD-L1 expression, which is a protein found on some cancer cells that helps them hide from the immune system.
  • If you have AGA-positive disease, you must have already received targeted therapy, which is a type of treatment designed to attack specific molecules involved in cancer growth.
  • Your cancer must be measurable, meaning the tumors are large enough to be clearly seen and tracked using standard medical imaging rules known as RECIST.
  • You must have a performance status of 0 or 1, according to the Eastern Cooperative Oncology Group (ECOG) scale; this is a system used to measure how well you can perform daily activities and your overall physical health.
  • You are expected to have a life expectancy of at least 12 weeks.

Who cannot join the trial?

6 criteria

  • You have previously received treatment using B7-H3 targeted therapy, which is a type of medicine designed to attack a specific protein found on some cancer cells.
  • You have previously used an ADC with a topoisomerase inhibitor, which is a specialized drug that uses a "carrier" to deliver a strong chemical that stops cancer cells from multiplying. This rule applies specifically to patients who have not yet received treatment for their advanced or spreading cancer.
  • You are considered a candidate for locoregional treatment, which means treatments like surgery, specialized radiation, or procedures to destroy a tumor that aim to completely remove or control the cancer in one specific area.
  • You have a history of significant hematologic toxicity, which means your previous medical treatments caused serious damage to your blood cells.
  • You have experienced Grade 4 febrile neutropenia, which is a very severe condition where you have a very low count of white blood cells (the cells that fight infection) and also have a fever.
  • You have experienced recurrent or persistent Grade 3 to 4 neutropenia, which refers to a continuous or repeated low level of white blood cells that is considered severe.
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Investigated drugs

  • BNT324

    is an experimental therapy being tested to see how well it works and how safe it is when used to treat advanced lung cancer.

  • BNT327

    is an experimental therapy that is being studied in combination with another medication to evaluate its effectiveness and safety in patients with advanced lung cancer.

What is already known about the treatment

  • BNT324

    This medication is administered as a powder that is mixed into a liquid and given through an intravenous infusion into a vein. Currently being studied in clinical trials, it is being investigated as a potential treatment for advanced lung cancer. It works at a molecular level by targeting specific proteins on the surface of cancer cells to help the immune system recognize and attack them. This substance is classified as an experimental immunotherapy agent.

  • BNT327

    This substance is provided as a powder for concentrate that is dissolved in a solution and administered via intravenous infusion. It is currently under investigation in medical research to determine its effectiveness in treating advanced stages of lung cancer. At the molecular level, it functions by interacting with specific pathways to stimulate the body's natural defenses against tumor growth. It is classified as an experimental immunotherapy medication.

Investigated diseases

  • Non-small cell lung cancer

    This is a type of cancer that starts in the cells of the lungs. It is the most common form of lung cancer and typically develops in the outer parts of the lungs. The disease often begins as a mass of abnormal cells that can grow and spread to nearby tissues. As it progresses, the cancer cells may move to other parts of the body through the blood or lymph system. It can present in different forms, such as adenocarcinoma or squamous cell carcinoma.

  • Small cell lung cancer

    This is a specific type of lung cancer that is characterized by the rapid growth of abnormal cells. It often starts in the center of the lungs near the large airways. The disease typically progresses quickly and is known for its tendency to spread to other organs early on. It is categorized by the presence of small, round cells when viewed under a microscope.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-520238-31-01Protocol codeBNT324-01Estimated enrolment581 patientsSponsorBioNTech SE

sourced from the EU Clinical Trials Register and site verification

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