RecruitingPhase 1Phase 2NCT07079631

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

A Phase I/II, Randomized, Multi-site Trial to Investigate the Efficacy and Safety of BNT314 in Combination With BNT327 and Chemotherapy in Participants With Metastatic Colorectal Cancer


Sponsor

BioNTech SE

Enrollment

482 participants

Start Date

Jul 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized, multi-site, three-part study will test a new treatment called BNT314, which is designed to help the body's immune system fight cancer in combination with another new treatment (BNT327, which is an immune checkpoint inhibitor) and chemotherapy in participants with metastatic colorectal cancer (mCRC). This study will enroll participants with microsatellite stable or mismatch repair proficient (MSS/pMMR) mCRC who did not respond well to their first schema of chemotherapy. In one part of the study (i.e., Part B) mCRC participants will be enrolled, who have not received any systemic therapy before for their cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two new investigational drugs — BNT314 and BNT327 — in combination with standard chemotherapy for people with advanced colorectal cancer that has spread (metastatic). The study is testing whether these new drugs can help the immune system fight the cancer better than chemotherapy alone. **You may be eligible if...** - You have confirmed colorectal cancer that cannot be surgically removed and has a specific tumor profile (called MSS/pMMR) - You have measurable disease and are in good general health (ECOG 0–1) - You can provide a tumor tissue sample - Specific treatment history requirements apply depending on which part of the study you are entering (some require prior treatment, some do not) **You may NOT be eligible if...** - Your tumor is MSI-H (a specific tumor type that responds differently to immunotherapy) - You have received prior immunotherapy or certain other targeted therapies - You have significant heart disease, uncontrolled fluid around the lungs or heart, or active brain metastases - You have a history of autoimmune disease or have received an organ transplant - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBNT314

Intravenous (IV) infusion

DRUGBNT327

IV infusion

DRUGSoC chemotherapy treatment 1

IV infusion / IV bolus

DRUGSoC chemotherapy treatment 2

IV infusion / IV bolus / oral

DRUGBevacizumab

IV infusion


Locations(14)

Yale University

New Haven, Connecticut, United States

START Midwest

Grand Rapids, Michigan, United States

Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center

Cleveland, Ohio, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Hämatologisch-Onkologische Praxis Eppendorf - HOPE

Hamburg, Germany

Asklepios Tumorzentrum Hamburg

Hamburg, Germany

National Cancer Center Hospital

Chūōku, Japan

National Cancer Center Hospital East

Kashiwa, Japan

Hospital HM Nou Delfos

Barcelona, Spain

Vall D'Hebrón Hospital

Barcelona, Spain

Centro Integral Oncologico Clara Campal

Madrid, Spain

Guy's & St Thomas' NHS Foundation Trust, Guy's Hospital

London, United Kingdom

Christie NHS Foundation

Manchester, United Kingdom

The Royal Marsden NHS

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07079631


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