OncoMatch/Clinical Trials/NCT07079631
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
Is NCT07079631 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments for metastatic colorectal cancer.
Treatment: BNT314 · BNT327 · SoC chemotherapy treatment 1 · SoC chemotherapy treatment 2 · Bevacizumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MSH2 proficient mismatch repair
confirmed non-microsatellite instability-high (non-MSI-H)/pMMR mCRC per Food and Drug Administration (FDA)/European Commission (EC) approved test or based on local testing
Required: MSH6 proficient mismatch repair
confirmed non-microsatellite instability-high (non-MSI-H)/pMMR mCRC per Food and Drug Administration (FDA)/European Commission (EC) approved test or based on local testing
Required: MLH1 proficient mismatch repair
confirmed non-microsatellite instability-high (non-MSI-H)/pMMR mCRC per Food and Drug Administration (FDA)/European Commission (EC) approved test or based on local testing
Required: PMS2 proficient mismatch repair
confirmed non-microsatellite instability-high (non-MSI-H)/pMMR mCRC per Food and Drug Administration (FDA)/European Commission (EC) approved test or based on local testing
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: epithelial cell-adhesion molecule targeted therapy
Prior treatment with epithelial cell-adhesion molecule or 4-1BB targeted or immunotherapy
Cannot have received: 4-1BB targeted therapy
Prior treatment with epithelial cell-adhesion molecule or 4-1BB targeted or immunotherapy
Cannot have received: immunotherapy
Prior treatment with epithelial cell-adhesion molecule or 4-1BB targeted or immunotherapy
Cannot have received: immune checkpoint inhibitor
Prior treatment with immune checkpoint inhibitors or programmed death-ligand 1 (PD[L]-1)/vascular endothelial growth factor bispecific antibody
Cannot have received: PD-L1/VEGF bispecific antibody
Prior treatment with immune checkpoint inhibitors or programmed death-ligand 1 (PD[L]-1)/vascular endothelial growth factor bispecific antibody
Lab requirements
Blood counts
adequate organ and bone marrow function within ≤7 days of Day 1 as defined in the protocol
Kidney function
adequate organ and bone marrow function within ≤7 days of Day 1 as defined in the protocol
Liver function
adequate organ and bone marrow function within ≤7 days of Day 1 as defined in the protocol
Cardiac function
left ventricular ejection fraction <50% by echocardiogram within 28 days before randomization/enrollment [excluded]
adequate organ and bone marrow function within ≤7 days of Day 1 as defined in the protocol. Have left ventricular ejection fraction <50% by echocardiogram within 28 days before randomization/enrollment [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Yale University · New Haven, Connecticut
- START Midwest · Grand Rapids, Michigan
- Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center · Cleveland, Ohio
- The University of Texas MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07079631 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior epithelial cell-adhesion molecule targeted therapy, 4-1BB targeted therapy, immunotherapy disqualifies patients from enrollment.
Does this trial require MSH2?
Yes, MSH2 proficient mismatch repair is a required biomarker for enrollment.
Does this trial require MSH6?
Yes, MSH6 proficient mismatch repair is a required biomarker for enrollment.
Does this trial require MLH1?
Yes, MLH1 proficient mismatch repair is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify