๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-20

A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors (NCT07070232)

A Phase I/II, Open-label, Adaptive Two-part Trial to Evaluate the Safety, Efficacy, Optimal Dose and Pharmacokinetics of BNT326 as Monotherapy and in Combination With Cancer Immunotherapies in Participants With Advanced Solid Tumors

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: BioNTech SE

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with immunotherapeutic agents (Part 2) in participants with histologically or cytologically confirmed solid tumors that are advanced (i.e., either metastatic or recurrent tumors with no further definitive treatment possible) and/or have relapsed/progressed after prior therapy.

Who can join: Review the eligibility criteria below.

Location: Mayo Clinic Arizona โ€” Phoenix, Arizona

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (67 Sites)

Showing the first 25 of 67 sites.

  • Mayo Clinic Arizona โ€” Phoenix, Arizona
  • University of California San Francisco โ€” San Francisco, California
  • Hartford Healthcare โ€” Hartford, Connecticut
  • Yale University โ€” New Haven, Connecticut
  • Florida Cancer Specialists โ€” Sarasota, Florida
  • Moffitt Cancer Center โ€” Tampa, Florida
  • Dana Farber Cancer Institute โ€” Boston, Massachusetts
  • Massachusetts General Hospital โ€” Boston, Massachusetts
  • Brigitte Harris Cancer Pavilion BHCP โ€” Detroit, Michigan
  • START Midwest, LLC โ€” Grand Rapids, Michigan
  • Memorial Sloan Kettering Hospital โ€” New York, New York
  • Duke Cancer Institute โ€” Durham, North Carolina
  • Cleveland Clinic Taussig Cancer Center โ€” Cleveland, Ohio
  • University of Pittsburgh Medical Center โ€” Pittsburgh, Pennsylvania
  • The University of Texas MD Anderson Cancer Center โ€” Houston, Texas
  • South Texas Accelerated Research Therapeutics (START), LLC โ€” San Antonio, Texas
  • START Mountain Region โ€” West Valley City, Utah
  • The Board of Regents of the University of Wisconsin โ€” Madison, Wisconsin
  • Blacktown Hospital โ€” Blacktown, New South Wales
  • St Vincent's Hospital Sydney โ€” Darlinghurst, New South Wales
  • Melanoma Institute Australia โ€” Wollstonecraft, New South Wales
  • Tasman Oncology Research Ltd โ€” Southport, Queensland
  • Cancer Research SA โ€” Adelaide, South Australia
  • Peninsula and South Eastern Haematology & Oncology Group โ€” Frankston, Victoria
  • Austin Health โ€” Heidelberg, Victoria

๐Ÿ“ž 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.

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก 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.
๐Ÿ›๏ธ View Official NIH Record โ†—