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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 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 482

Last updated 2026-04-17

No results posted yet for this 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

Interventions

BIOLOGICAL

BNT314

Intravenous (IV) infusion

DRUG

BNT327

IV infusion

DRUG

SoC chemotherapy treatment 1

IV infusion / IV bolus

DRUG

SoC chemotherapy treatment 2

IV infusion / IV bolus / oral

DRUG

Bevacizumab

IV infusion

Sponsors & Collaborators

  • Genmab

    collaborator INDUSTRY

  • BioNTech SE

    lead INDUSTRY

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-18
Primary Completion
2030-12-31
Completion
2031-05-31
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Japan
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07079631 on ClinicalTrials.gov