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RecruitingPHASE1, PHASE2INTERVENTIONAL

A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment BNT327 and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer

This study is testing new treatments, BNT314 and BNT327, alongside standard chemotherapy for people with advanced bowel cancer that has spread (metastatic colorectal cancer). The main goals are to find out if this treatment combination is safe, what the right dose is, and if it can help to shrink or slow down the cancer. It's for patients whose cancer hasn't responded well to their first chemotherapy, or for some patients who haven't had previous treatment for their advanced cancer. The study is divided into parts to first check safety and then to see how well it works compared to current treatments.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
BioNTech SE
Enrolment target
482
Start
18 Jul 2025
Estimated completion
01 May 2031

What is this study about?

This clinical trial is designed to investigate a new approach to treating advanced bowel (colorectal) cancer that has spread to other parts of the body (known as metastatic colorectal cancer). The study is focusing on two new treatments, BNT314 and BNT327, used in combination with standard chemotherapy. BNT314 is designed to boost your body's own immune system to fight against cancer, and BNT327 is another type of immune treatment that helps unblock the body's natural defences against cancer.

The trial has different stages. The first stages (Phase 1) are focused on safety. Researchers want to make sure the new treatments, alone and with chemotherapy, don't cause severe side effects and to find the best dose to use. The later stage (Phase 2) will then compare this new combination treatment against current standard chemotherapy to see if it's better at shrinking tumours or slowing down their growth. This is important for patients who haven't responded well to their first round of chemotherapy, or in some cases, for those who haven't had any treatment for their advanced cancer yet.

The overall aim is to find new and more effective ways to treat metastatic colorectal cancer, particularly for patients who have limited options. The study will carefully monitor participants' health and treatment effects throughout, with safety being a top priority.

Key takeaways

  • Tests new immune-boosting treatments (BNT314, BNT327) with chemotherapy.
  • For advanced bowel cancer that has spread (metastatic colorectal cancer).
  • Aims to check safety, find the right dose, and see if it shrinks tumours.
  • Could be for patients who haven't responded to previous chemotherapy or some who haven't had prior treatment.
  • Involves regular check-ups and monitoring for side effects.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be part of this study, you would generally need to have bowel cancer that has spread (advanced colorectal cancer) and has been confirmed under a microscope. Your cancer should not be of a specific type called `MSI-H` or `deficient mismatch repair`. You need to have cancer that can be measured, and you'll typically need to provide a recent tumour sample for tests. Your general health and ability to do daily activities should also be good, and you should be expected to live for at least 12 weeks.

Depending on which part of the study you might join, you may need to have already received at least two other types of treatment for your advanced cancer and found that your cancer progressed. Alternatively, some parts of the study are for people who haven't received any treatment for their advanced bowel cancer yet. You won't be able to join if your cancer is `MSI-H` or `deficient mismatch repair`, or if you've already had certain types of immune-boosting treatments for cancer.

It's important that your organs, like your liver and kidneys, are working well, and that you haven't recently had other treatments that might interfere with the study drugs. The research team will carefully check all these requirements with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do I have advanced bowel cancer that has spread?
  2. Has my doctor told me my cancer is *not* MSI-H or deficient mismatch repair?
  3. Am I generally well enough to take part in a study?
  4. Have I had previous chemotherapy for my advanced cancer that didn't work well, or no treatment for advanced cancer yet (depending on the study part)?
  5. Have I not had certain immune-boosting cancer treatments before?
Answer every question to see your result.

What does participation involve?

If you join this study, it involves a few stages. First, there's a 'screening period' where tests are done to make sure you meet all the requirements. After that, you'll enter the 'treatment period', where you’ll receive the study drugs and regular check-ups. You'll continue treatment for as long as it's helping you, or for about 6 to 10 months on average, unless your cancer gets worse or you can't tolerate the treatment anymore.

Even after you stop taking the study drugs, there will be 'safety follow-up' to monitor your health and any side effects. There's also a 'long-term survival follow-up' period to monitor your overall health over a longer time. The study team will be regularly checking your safety, and for one part of the study, an independent group will also oversee patient safety.

Potential risks and benefits

Participating in a clinical trial means you might benefit from a new treatment before it's widely available. The potential benefits of this study include the possibility that the new combination of treatments could shrink your tumours or slow their growth, especially if other treatments haven't worked well. However, there's no guarantee the treatment will work for you. There are also potential risks, as new treatments can have side effects that aren't fully known yet. The study team will carefully monitor you for any side effects, and you'll be told about known risks before you decide to join. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (14)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Yale University
    Verified postcode
    New Haven, United States· Recruiting
  • START Midwest
    Verified postcode
    Grand Rapids, United States· Recruiting
  • Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center
    Verified postcode
    Cleveland, United States· Recruiting
  • The University of Texas MD Anderson Cancer Center
    Verified postcode
    Houston, United States· Recruiting
  • Hämatologisch-Onkologische Praxis Eppendorf - HOPE
    Verified postcode
    Hamburg, Germany· Recruiting
  • Asklepios Tumorzentrum Hamburg
    Verified postcode
    Hamburg, Germany· Recruiting
  • National Cancer Center Hospital
    Verified postcode
    Chūōku, Japan· Recruiting
  • National Cancer Center Hospital East
    Verified postcode
    Kashiwa, Japan· Recruiting
  • Hospital HM Nou Delfos
    Verified postcode
    Barcelona, Spain· Recruiting
  • Vall D'Hebrón Hospital
    Verified postcode
    Barcelona, Spain· Recruiting
  • Centro Integral Oncologico Clara Campal
    Verified postcode
    Madrid, Spain· Recruiting
  • Guy's & St Thomas' NHS Foundation Trust, Guy's Hospital
    Verified postcode
    London, United Kingdom· Recruiting

Common questions

What is 'advanced colorectal cancer'?

This means bowel cancer that has spread beyond where it started to other parts of your body, also called metastatic cancer.

What are BNT314 and BNT327?

They are new, investigational treatments that aim to help your body's immune system fight the cancer.

What is 'chemotherapy'?

Chemotherapy is a standard treatment for cancer that uses drugs to kill cancer cells or slow their growth.

How long will I be on treatment?

You'll typically be on treatment for about 6-10 months, or longer if it's helping and you're tolerating it well.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without it affecting your future medical care.

How to find out more

BioNTech clinical trials patient information

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Clinical Study to Test if an Investigational Treatment Cal…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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