Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid Tumors
← catalyst calendarNCT06150183 · readout ≤ 314 d
Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →. With Genmab.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
41actual
Sites
14
Countries
Belgium, Denmark, Japan +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-11-30 | actual | When the study began enrolling |
| Primary completion | Jun 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2023-11-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Advanced Malignant Solid Tumor
Intervention
- Biological: BNT314
Primary outcomes
what the primary-completion date above is the date OFOccurrence of dose-limiting toxicity within a cohort
measured 21 days from the first dose administration
Number and percentage of patients with occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥ 3, serious, fatal TEAE by relationship
measured from first dose of study treatment to 90 days after last dose of study treatment
Number and percentage of patients with occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAE
measured from first dose of study treatment to 90 days after last dose of study treatment
Number and percentage of patients with occurrence of Grade ≥ 3 abnormal safety laboratory parameters
measured from first dose of study treatment to 90 days after last dose of study treatment
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