Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study of BNT326 alone and with BNT327 in patients with advanced solid tumors: Testing safety and effectiveness of new cancer treatments

Fast replyInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial focuses on testing a new treatment for advanced solid tumors. The study investigates two experimental medications: BNT326 and BNT327, which are given through intravenous infusion. Both medications come in the form of a powder that is mixed into a solution before being administered into a vein.

The purpose of this research is to determine if BNT326 is safe and potentially helpful when used alone or in combination with other cancer treatments, including BNT327. The study is divided into two parts. In the first part, participants receive only BNT326. In the second part, participants receive BNT326 together with other cancer treatments that help the immune system fight cancer cells.

During the study, doctors will monitor how participants respond to the treatment and check for any side effects. The medications will be given through an infusion into a vein at a medical facility. Participants will need to visit the medical center regularly for treatment and health evaluations. The study team will track how the tumors respond to treatment using various medical tests and imaging.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial Treatment Phase

    You will receive BNT326 through an intravenous infusion (medication given directly into a vein).

    The treatment will be given either alone (Part 1 of the study) or in combination with other medications such as BNT327 (Part 2 of the study).

    Your doctor will monitor your health status and perform regular medical examinations.

  2. Step 2

    Health Monitoring

    Your tumor response will be measured regularly using imaging scans to track any changes in size.

    Blood samples will be collected to measure the levels of medication in your body (pharmacokinetics).

    Regular checks will be performed to monitor for any side effects or adverse reactions to the treatment.

  3. Step 3

    Follow-up Period

    After completing the treatment, you will be monitored for 42 days after your last dose.

    During this period, any side effects will be recorded and assessed.

    Additional follow-up visits will continue for up to 1 year after your last dose to check for immune system responses to the medication.

  4. Step 4

    Study Completion

    The study will end if your disease progresses, if you experience unacceptable side effects, or if you complete the planned treatment schedule.

    Your doctor will discuss future treatment options with you after the study ends.

    The overall study is expected to continue until May 2028.

Who can join the trial?

17 criteria

  • Must be 18 years or older
  • Must be able to understand and provide written informed consent for participation in the study
  • Must have advanced solid tumors confirmed by tissue or cell examination, either recurring or with spread to other parts of the body
  • Must have tumors that can be measured using standard imaging criteria (RECIST 1.1)
  • Must provide a tumor tissue sample. In cases where this is not possible, special approval is required
  • Must have good physical functioning ability (ECOG status 0 or 1, meaning able to perform daily activities with minimal assistance)
  • Must have adequate organ and bone marrow function, confirmed by tests within 7 days before study start
  • Must wait an appropriate time after previous treatments before starting the study
  • For women who can become pregnant:
    • Must have a negative pregnancy test
    • Must use effective birth control methods
    • Must not donate eggs during the study
    • For men who can father children:
      • Must use condoms during the study
      • Must ask partners to use effective birth control
      • Must not donate sperm during the study
      • Must be willing to follow the study schedule, including all visits and assessments
      • Must not participate in any other clinical trials during this study
      • For participants in Part 2 of the study: Must meet specific protein levels in urine tests

Who cannot join the trial?

14 criteria

  • Individuals under 18 years of age
  • Patients who have received any investigational drug (drugs being tested in research but not yet approved) within 28 days before starting this study
  • Patients with active brain metastases (cancer that has spread to the brain) or spinal cord compression
  • Those with serious heart conditions, including:
    • Uncontrolled high blood pressure
    • Unstable heart disease
    • Heart attack within the past 6 months
    • Patients with active, uncontrolled infections
    • Those with known HIV infection (Human Immunodeficiency Virus)
    • Patients with active hepatitis B or C infection
    • Pregnant or breastfeeding women
    • Patients with severe kidney or liver problems
    • Those who have had major surgery within 4 weeks before starting the study
    • Patients currently participating in other clinical trials
    • Individuals with known allergies to the study medication or its components
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • BNT326

    is an investigational medication being studied for the treatment of advanced solid tumors. It is being tested both as a standalone treatment and in combination with other cancer treatments. This is a new drug that is still being researched to understand how well it works and how safe it is for patients with advanced cancers.

  • BNT327

    is one of the cancer immunotherapy medications that may be combined with BNT326 in this trial. Immunotherapy works by helping the body's immune system fight cancer cells. This medication is being studied as part of the combination treatment phase of the trial.

What is already known about the treatment

  • BNT326

    An investigational medication currently being studied in Phase I/II clinical trials for the treatment of advanced solid tumors. It is being evaluated both as a monotherapy and in combination with other cancer immunotherapies, particularly BNT327. The medication is being tested to assess its safety profile, optimal dosing, and pharmacokinetic properties in cancer patients. While the exact mechanism of action and administration route are not specified in the trial data, this drug represents a new approach in cancer immunotherapy research.

  • BNT327

    An investigational cancer immunotherapy medication that is being studied in combination with BNT326 for the treatment of advanced solid tumors. This drug is part of a Phase I/II clinical trial examining combination therapy approaches in cancer treatment. The specific administration method and molecular mechanism are not detailed in the trial information, but it is being evaluated as part of an innovative immunotherapy combination strategy.

Investigated diseases

Advanced solid tumors - A condition where abnormal cells form solid masses or tumors that have grown and spread beyond their original location. These tumors can develop in various parts of the body such as the lungs, breast, colon, or other organs. The disease typically progresses through stages where cancer cells multiply and can potentially spread to nearby tissues. Solid tumors are characterized by the formation of dense masses of cells that can be detected through imaging. These tumors can vary in size and growth rate, and may affect the function of surrounding tissues and organs.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517261-16-00Protocol codeBNT326-01Estimated enrolment1 438 patientsSponsorBioNTech SE

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

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).