RecruitingMetastatic Colorectal Cancer
A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment Pumitamig (BNT327) and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
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About this study
This randomized, multi-site, three-part study will test a new treatment called BNT314, which is designed to help the body's own defense to fight cancer in combination with another new treatment (pumitamig, which is a cancer immunotherapy drug also known as BNT327 and PM8002) and chemotherapy in participants with metastatic colorectal cancer (mCRC).
Sponsor: BioNTech SE
You may qualify if…
- ✓ Have histologically confirmed metastatic colorectal cancer and radiographically documented disease progression after ≥2 prior lines of systemic therapy for metastatic disease as defined in the protocol.
- ✓ Have progressed following first-line chemotherapy as specified in the protocol.
- ✓ Have not received prior systemic therapy for MSS/pMMR mCRC. Participants who received chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease in the neoadjuvant or adjuvant setting are eligible for the study if therapy was completed at least 6 months prior to initiation of study treatment.
- ✓ Other cohort-specific inclusion criteria apply.
- ✓ Key Exclusion Criteria:
- ✓ Confirmed MSI-H/deficient mismatch repair mCRC (per FDA/CE approved test or based on local testing).
- ✓ Prior treatment with epithelial cell-adhesion molecule or 4-1BB targeted or immunotherapy.
- ✓ Prior treatment with immune checkpoint inhibitors or programmed death-ligand 1 (PD\[L\]-1)/vascular endothelial growth factor bispecific antibody.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07079631 · last updated 2026-07-01