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NCT07079631 · ClinicalTrials.gov registry record · 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
A Phase 1 study of Metastatic Colorectal Cancer, sponsored by BioNTech SE.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 482
- Enrollment target
- 13
- Study locations
NCT07079631 is a Phase 1 study of Metastatic Colorectal Cancer that is actively recruiting participants, run by BioNTech SE. The registered enrollment target is 482 participants, above the 175-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (175% higher). The trial reports 13 study locations across 5 states.
The verdict
NCT07079631, a Phase 1 study of Metastatic Colorectal Cancer, is actively recruiting participants, sponsored by BioNTech SE.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 482 participants
- Enrollment target
- 13
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 482 participants |
| Start Date | 2025-07-18 |
| Est. Completion | 2031-05 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 482 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 175-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (175% higher). The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.
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.
NCT07079631 reports 13 study locations spanning 5 distinct geographic areas - top geographies include Other, Connecticut, Michigan.
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.
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).
Who is sponsoring clinical trial NCT07079631?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.