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Study on the Safety and Effects of BNT314 Alone or with Pembrolizumab for Patients with Advanced Solid Tumors

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What is this trial about?

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

This clinical trial is focused on studying the safety and initial effectiveness of a new treatment for patients with advanced malignant solid tumors. These are types of cancer that have spread to other parts of the body and are not easily removed by surgery. The trial will test a new medication called BNT314, which is given as a solution through an intravenous infusion, meaning it is delivered directly into the bloodstream. In some parts of the study, BNT314 will be used alone, while in others, it will be combined with another medication called pembrolizumab, also known by the brand name Keytruda. Pembrolizumab is an immune checkpoint inhibitor, a type of drug that helps the immune system recognize and attack cancer cells.

The purpose of the study is to find the best dose of BNT314 that can be safely given to patients and to see how well it works against cancer. The study will start with a phase called dose escalation, where different doses of BNT314 will be tested to find the maximum amount that can be given without causing severe side effects. After this, the study will move to a phase called dose expansion, where more patients will receive the treatment to gather more information about its safety and effectiveness. Some patients will receive BNT314 alone, while others will receive it in combination with pembrolizumab.

Throughout the study, patients will be closely monitored for any side effects and to see how their cancer responds to the treatment. The study aims to provide valuable information about the potential of BNT314 as a new treatment option for people with advanced cancer. The trial is expected to continue until 2027, with recruitment of participants starting in late 2023. Participants will receive regular check-ups and assessments to ensure their safety and to track the progress of their treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, the patient will be required to provide informed consent. This involves signing and dating a consent form to confirm understanding and agreement to participate in the trial.

  2. Step 2

    Initial screening

    The patient will undergo a series of tests to ensure eligibility. These tests will assess kidney function, pancreas function, and other health parameters. Women of childbearing potential will need to take a pregnancy test.

  3. Step 3

    Treatment phase

    The patient will receive the medication BNT314 through an intravenous infusion. The dosage will be determined during the trial to find the maximum tolerated dose.

    In some cases, the patient may also receive pembrolizumab in combination with BNT314. This combination aims to evaluate the safety and preliminary effectiveness of the treatment.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, the patient will have regular visits to monitor health and response to the treatment. This includes laboratory tests and assessments of any side effects.

    The patient will be observed for any adverse events and the effectiveness of the treatment will be evaluated.

  5. Step 5

    End of treatment

    After completing the treatment phase, the patient will continue to be monitored for a period of 90 days to assess any long-term effects and overall health status.

Who can join the trial?

19 criteria

  • Must be able to voluntarily give informed consent by signing and dating the informed consent form before starting any trial-specific procedures.
  • Must have adequate kidney function, which means the kidneys are working well enough, as determined by a test called Glomerular Filtration Rate (GFR) that should be 45 or higher.
  • Must have adequate pancreas function, meaning the pancreas is working well, as shown by normal levels of certain enzymes in the blood and no signs of pancreatitis, which is inflammation of the pancreas.
  • Patients who can have children must have a negative pregnancy test at the start of the trial.
  • Patients who can have children must agree to use a highly effective form of birth control and ensure their male partners use condoms with a sperm-killing agent during the trial and for 60 days after the last treatment.
  • Patients who can have children must agree not to donate eggs for assisted reproduction during the trial and for 60 days after the last treatment.
  • Men who are sexually active and have not had certain surgeries to prevent pregnancy must agree to use condoms with a sperm-killing agent and ensure their female partners use a highly effective form of birth control during the trial and for 90 days after the last treatment.
  • Men must agree not to donate sperm during the trial and for 90 days after the last treatment.
  • For monotherapy dose escalation only: Must have a confirmed advanced malignant solid tumor, which means a serious type of cancer, and have experienced disease progression after standard therapy or were unable to tolerate or not eligible for standard therapy.
  • For backfill cohorts only: Must have a previously documented metastatic or advanced malignant solid tumor of selected cancers and have received at least one prior therapy for advanced or metastatic disease.
  • For combination therapy and dose expansion only: Must have a confirmed locally advanced or metastatic selected cancer and have documented disease progression after standard therapy.
  • Must be willing and able to follow the trial schedule, including visits, treatment, tests, and lifestyle restrictions, and understand and follow trial-related instructions.
  • Must be 18 years of age or older at the time of giving informed consent.
  • Must have measurable disease according to a specific guideline called RECIST v1.1, which is a way to measure cancer response to treatment.
  • Must have a life expectancy of more than 3 months.
  • Must have an ECOG performance score of 0 or 1, which is a scale used to assess how well a patient can perform daily activities.
  • Must have adequate blood clotting function, as shown by certain blood tests being within normal limits.
  • Must have adequate bone marrow function, which means the bone marrow is producing enough blood cells, as shown by certain blood tests.
  • Must have adequate liver function, as shown by certain blood tests being within normal limits.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied, which is advanced or metastatic malignant solid tumors.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have other medical conditions that might interfere with the study treatment or its evaluation.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies or reactions to the study medication or similar drugs.
  • Patients who have certain infections or diseases that could affect the study results.
  • Patients who are taking medications that might interfere with the study treatment.
  • Patients who have a history of substance abuse or other factors that might affect their ability to participate in the study.
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Investigated drugs

  • BNT314

    is a new medication being tested for the first time in humans. It is being studied to find out how safe it is and to determine the best dose to use in future studies. This medication is being tested on its own to see how it works in patients with advanced solid tumors.

  • Pembrolizumab

    is an immune checkpoint inhibitor that helps the body's immune system fight cancer. In this trial, it is being used in combination with BNT314 to see if the two medications together can help treat advanced solid tumors more effectively.

What is already known about the treatment

BNT314 – BNT314 is administered as an injection, typically given directly into the bloodstream. It is currently in clinical trials, being studied for its safety and effectiveness in treating advanced or metastatic malignant solid tumors. The main therapeutic indication for BNT314 is to target and treat these types of tumors, either alone or in combination with another medication called pembrolizumab. At the molecular level, BNT314 works by interacting with specific proteins on cancer cells, potentially inhibiting their growth and spread. It is classified as an investigational cancer therapy, focusing on enhancing the body's immune response to fight cancer cells.

Investigated diseases

Advanced or Metastatic Malignant Solid Tumors – These are cancers that originate in solid organs or tissues and have progressed to an advanced stage, meaning they have grown significantly or spread to other parts of the body. The term "metastatic" indicates that the cancer cells have moved from the original site to other areas, forming new tumors. This progression can occur through the bloodstream or lymphatic system. As the disease advances, it can affect the function of the organs involved, leading to various symptoms depending on the location and size of the tumors. The growth and spread of these tumors can be unpredictable, and they may affect multiple systems in the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-506053-38-00Protocol codeBNT314-01Estimated enrolment103 patientsSponsorBioNTech SE

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).