🏛️ Verified NIH Record • Updated 2026-06-30

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 (NCT07079631)

A Phase I/II, Randomized, Multi-site Trial to Investigate the Efficacy and Safety of BNT314 in Combination With Pumitamig and Chemotherapy in Participants With Metastatic Colorectal Cancer

🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: BioNTech SE

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: Yale University — New Haven, Connecticut

Age range: 18 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (14 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
  • Hämatologisch-Onkologische Praxis Eppendorf - HOPE — Hamburg,
  • Asklepios Tumorzentrum Hamburg — Hamburg,
  • National Cancer Center Hospital — Chūōku,
  • 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,

📞 Contact the Study Coordinator

Phone: (496) 131-9084

Email: patients@biontech.de

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗