Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

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

NCT07079631 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Bevacizumab
  • DRUG BNT327
  • BIOLOGICAL BNT314
  • DRUG SoC chemotherapy treatment 1
  • DRUG SoC chemotherapy treatment 2

Study Locations (13)

Other

  • Hämatologisch-Onkologische Praxis Eppendorf - HOPE — Hamburg
  • Asklepios Tumorzentrum Hamburg — Hamburg
  • National Cancer Center Hospital East — Kashiwa
  • Hospital HM Nou Delfos — Barcelona
  • Vall D'Hebrón Hospital — Barcelona
  • Centro Integral Oncologico Clara Campal — Madrid
  • Guy's & St Thomas' NHS Foundation Trust, Guy's Hospital — London
  • Christie NHS Foundation — Manchester
  • The Royal Marsden NHS — Sutton

Connecticut

  • Yale University — New Haven

Michigan

  • START Midwest — Grand Rapids

Ohio

  • Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center — Cleveland

Texas

  • The University of Texas MD Anderson Cancer Center — Houston

Trial Details

FieldValue
Enrollment Target 482 participants
Start Date 2025-07-18
Est. Completion 2031-05
Phase Phase 1

Sponsor

BioNTech SE

123 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07079631

The ClinicalTrials.gov registry entry for NCT07079631 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 482 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 123 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions — of which Bevacizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07079631 reports 13 study locations spanning 5 distinct geographic areas — top geographies include Other, Connecticut, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07079631 about?

NCT07079631 is a clinical study titled "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 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 colorect...

What is the current status of trial NCT07079631?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 482 participants. The study started on 2025-07-18. Estimated completion is 2031-05.

What conditions does trial NCT07079631 study?

This clinical trial studies the following conditions: Metastatic Colorectal Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07079631?

The interventions under investigation include: Bevacizumab (DRUG), BNT327 (DRUG), BNT314 (BIOLOGICAL), SoC chemotherapy treatment 1 (DRUG), SoC chemotherapy treatment 2 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07079631?

This trial is sponsored by BioNTech SE, which has 123 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07079631 being conducted?

This trial has 13 study locations across Connecticut, Michigan, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial