Clinical Trial

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

Recruiting Phase 1
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2024-12-19; most recent amendment 2026-02-10.
Status change: Not Yet Recruiting → Recruiting 2025-01-23
Trial Details
NCT Number NCT06750185
Lead Sponsor BioNTech SE
Conditions Advanced Solid Tumor
Enrollment 39 participants
Start Date 2025-01-13
Primary Completion 2028-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-02-11