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 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 system

Trial Details

NCT ID
NCT07079631
Phase
PHASE1 / PHASE2
Sponsor
BioNTech SE
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • BNT314
  • BNT327
  • SoC chemotherapy treatment 1
  • SoC chemotherapy treatment 2
  • Bevacizumab
Locations (sample)
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Grand Rapids, Michigan, United States|42.96336,-85.66809
  • Cleveland, Ohio, United States|41.4995,-81.69541
  • Houston, Texas, United States|29.76328,-95.36327
  • Hamburg, Germany|53.55073,9.99302

Key Eligibility Criteria

  • Have unresectable histologically confirmed adenocarcinoma of the colon or rectum.
  • Have confirmed non-microsatellite instability-high (non-MSI-H)/pMMR mCRC per Food and Drug Administration (FDA)/European Commission (EC) approved t…
  • Have measurable disease defined by RECIST v1.1.
  • Must provide a tumor tissue sample (formalin-fixed, paraffin-embedded or tissue slides) collected before C1D1 for enrollment. A newly obtained tumo…

For full eligibility, visit ClinicalTrials.gov.

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