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

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario Hm Sanchinarro	Madrid	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Gasthuiszusters Antwerpen	Antwerp	Belgium
Hospital Hm Nou Delfos	Barcelona	Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Uodgagplpqnyczdmtennp Egaqi Api	Essen	Germany
Iuyahxlv Riwbbtbcb Pah Ly Siafvh Drc Tqvnol Dhol Awptyuz Iivr Sgfteo	Meldola	Italy
Kthdkndc dnc Uwqlnghivvwi Mbgrwggw Add	Munich	Germany
Hhdcduxv Vncb ddfwzbmp	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	18.11.2025
Germany	Recruiting	18.11.2025
Italy	Recruiting	18.11.2025
Spain	Recruiting	18.11.2025

Trial locations

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.

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 ID:

2024-517261-16-00

Protocol code:

BNT326-01

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?