๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-02-10

Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors (NCT06750185)

A Phase I, First-in-human, Open-label, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BNT317 in Patients With Advanced Solid Tumors

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

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

This is a first-in-human (FIH), open-label, multiple-site, dose escalation study which will evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of increasing doses of BNT317 in participants with advanced solid tumors.

Who can join: Review the eligibility criteria below.

Location: Norton Cancer Institute PARENT โ€” Louisville, Kentucky

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 (11 Sites)

  • Norton Cancer Institute PARENT โ€” Louisville, Kentucky
  • START Midwest โ€” Grand Rapids, Michigan
  • Carolina BioOncology Institute, LLC โ€” Huntersville, North Carolina
  • Rhode Island Hospital โ€” East Providence, Rhode Island
  • MUSC Hollings Cancer Center โ€” Charleston, South Carolina
  • Mary Crowley Cancer Research โ€” Dallas, Texas
  • South Texas Accelerated Research Therapeutics (START), LLC โ€” San Antonio, Texas
  • Tasman Oncology Research Ltd โ€” Southport, Queensland
  • Cancer Research SA โ€” Adelaide,
  • Monash Medical Centre Clayton โ€” Clayton,
  • Scientia Clinical Research โ€” Randwick,

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†—