Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors
Recruiting now · Phase 1
Conditions studied: Advanced Solid Tumor
In brief
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.
Key facts
- Study ID
- NCT06750185
- Run by
- BioNTech SE
- People needed
- 39
- Starts
- 2025-01-13
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-02-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Norton Cancer Institute PARENT — Louisville, Kentucky, United States (enrolling)
- START Midwest — Grand Rapids, Michigan, United States (enrolling)
- Carolina BioOncology Institute, LLC — Huntersville, North Carolina, United States (enrolling)
- Rhode Island Hospital — East Providence, Rhode Island, United States (enrolling)
- MUSC Hollings Cancer Center — Charleston, South Carolina, United States (enrolling)
- Mary Crowley Cancer Research — Dallas, Texas, United States (enrolling)
- South Texas Accelerated Research Therapeutics (START), LLC — San Antonio, Texas, United States (enrolling)
- Tasman Oncology Research Ltd — Southport, Queensland, Australia (enrolling)
- Cancer Research SA — Adelaide, Australia (enrolling)
- Monash Medical Centre Clayton — Clayton, Australia (enrolling)
- Scientia Clinical Research — Randwick, Australia (enrolling)
Full record on ClinicalTrials.gov
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