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Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors
Sponsor: BioNTech SE
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
39
Start Date
2025-01-13
Completion Date
2028-06
Last Updated
2026-02-11
Healthy Volunteers
No
Conditions
Interventions
BNT317 DL1
Intravenous infusion
BNT317 DL2
Intravenous infusion
BNT317 DL3
Intravenous infusion
BNT317 DL4
Intravenous infusion
BNT317 DL5 (intermediate)
Intravenous infusion
BNT317 DL6 (intermediate)
Intravenous infusion
BNT317 DL7 (additional)
Intravenous infusion
Locations (11)
Norton Cancer Institute PARENT
Louisville, Kentucky, United States
START Midwest
Grand Rapids, Michigan, United States
Carolina BioOncology Institute, LLC
Huntersville, North Carolina, United States
Rhode Island Hospital
East Providence, Rhode Island, United States
MUSC Hollings Cancer Center
Charleston, South Carolina, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
South Texas Accelerated Research Therapeutics (START), LLC
San Antonio, Texas, United States
Tasman Oncology Research Ltd
Southport, Queensland, Australia
Cancer Research SA
Adelaide, Australia
Monash Medical Centre Clayton
Clayton, Australia
Scientia Clinical Research
Randwick, Australia