Study of BNT314 and BNT327 with chemotherapy for patients with metastatic colorectal cancer

1 1 1

What is this study about?

This clinical trial focuses on patients with metastatic colorectal cancer, specifically studying a combination treatment approach. The study investigates two experimental treatments, BNT314 and BNT327, used together with standard chemotherapy. Metastatic colorectal cancer occurs when cancer that started in the colon or rectum has spread to other parts of the body.

The purpose of this research is to determine if combining BNT314 and BNT327 with chemotherapy is more effective and safe compared to standard treatment with bevacizumab and chemotherapy. BNT314 is given as a solution that goes directly into a vein through intravenous infusion. Similarly, BNT327 is first mixed with liquid and then also given through intravenous infusion.

The study is divided into three parts. The first two parts focus on finding the right dose and checking the safety of the treatment combination. The final part compares how well the new treatment combination works against the standard treatment. Throughout the study, doctors will monitor patients’ responses to the treatment and watch for any side effects that may occur.

1 Initial treatment preparation

Your doctor will confirm if you have advanced colorectal cancer that has spread to other parts of your body.

A tissue sample from your tumor will be collected and analyzed before starting the treatment.

Your overall health status and organ function will be evaluated to ensure you can safely participate in the treatment.

2 Treatment administration

You will receive two investigational medications: BNT314 and BNT327.

Both medications will be given through an intravenous infusion (directly into your vein).

BNT327 comes as a powder that will be prepared as a solution for infusion.

BNT314 comes ready as a solution for infusion.

These medications will be given together with standard chemotherapy treatment.

3 Monitoring during treatment

Your doctor will regularly check your health status and perform examinations to monitor how your tumor responds to treatment.

Regular scans will be performed to measure if the tumor is getting smaller, staying the same size, or growing.

Blood samples will be taken to check how your body processes the medications.

Any side effects you experience will be recorded and monitored.

4 Follow-up period

After completing the treatment, you will continue to be monitored for up to one year.

Regular check-ups will assess your overall health and any lasting effects from the treatment.

Your doctor will continue to track how your cancer responds to the treatment.

Who Can Join the Study?

You must have confirmed colon or rectal cancer (adenocarcinoma) that cannot be surgically removed
Your cancer must be metastatic (spread to other parts of the body) and have specific genetic characteristics (non-MSI-H/pMMR type)
Your cancer must be measurable using standard imaging methods (RECIST criteria)
You must be able to provide a tissue sample from your tumor before starting treatment
You must have good physical functioning ability, with an ECOG Performance Status of 0 or 1 (able to carry out all or most daily activities)
Your life expectancy must be at least 12 weeks
Your organs and bone marrow must be functioning well enough (as determined by blood tests)
You must have completed any previous cancer treatments and waited for the required time period before starting this study
You must meet additional specific requirements as outlined in the study protocol
You must be an adult (18 years or older)
Both men and women can participate in this study

Who Cannot Join the Study?

Prior treatment with anti-PDL1 or anti-CTLA4 therapy (types of immunotherapy)
Active or untreated brain metastases (cancer that has spread to the brain)
History of autoimmune disease requiring systemic treatment in the past 2 years
Uncontrolled high blood pressure or heart disease
Active or chronic infections, including hepatitis B, hepatitis C, or HIV
Major surgery within 28 days before starting the study treatment
Pregnant or breastfeeding women
Current participation in another clinical trial
Known allergies to study medications or their components
Serious medical conditions that could interfere with study participation
Active bleeding disorders or need for blood thinning medications
History of other cancers within the past 3 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
Psychological, social, or geographical conditions that would limit compliance with study requirements

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Haematologisch Onkologische Praxis Eppendorf	Hamburg	Germany
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Hospital Hm Nou Delfos	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
Hkirkbfm Vpwg dpfxksen	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	24.11.2025
Spain	Recruiting	24.11.2025

Trial locations

Investigated drugs:

Bnt314

BNT314 is an investigational drug being studied for the treatment of metastatic colorectal cancer. It is being tested in combination with other treatments to evaluate its safety and effectiveness in patients whose cancer has spread.

BNT327 is another investigational drug that is being studied in combination with BNT314. Together, these medications are being tested to see how well they work in treating patients with metastatic colorectal cancer.

Bevacizumab is a medication that works by blocking the growth of blood vessels that feed tumors. It is being used as a comparison treatment in this study alongside chemotherapy.

Chemotherapy refers to standard cancer-fighting drugs that are used to kill cancer cells or stop them from growing. In this trial, chemotherapy is being used in combination with the other study medications.

Metastatic colorectal cancer – A condition that begins as cancer in the colon or rectum and spreads to other parts of the body. The disease starts when abnormal cells grow out of control in the lining of the colon or rectum. Over time, these cancer cells can break away from the original tumor and travel through the blood or lymphatic system to form new tumors in distant organs, most commonly the liver and lungs. The disease typically develops gradually, first forming polyps in the intestinal wall, which may eventually become cancerous and spread beyond the original site.

Trial ID:

2025-521768-36-00

Protocol code:

BNT314-02

NCT ID:

NCT07079631

Trial Phase:

Human Pharmacology (Phase I) – Other

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of BNT314 and BNT327 with chemotherapy for patients with metastatic colorectal cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?