Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors
← catalyst calendarNCT06750185 · readout ≤ 681 d
Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
39estimated
Sites
11
Countries
Australia, United States
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 | 2025-01-13 | actual | When the study began enrolling |
| Primary completion | Jun 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2024-12-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Advanced Solid Tumor
Interventions
- Biological: BNT317 DL1
- Biological: BNT317 DL2
- Biological: BNT317 DL3
- Biological: BNT317 DL4
- Biological: BNT317 DL5 (intermediate)
- Biological: BNT317 DL6 (intermediate)
- Biological: BNT317 DL7 (additional)
Primary outcomes
what the primary-completion date above is the date OFOccurrence of DLTs
measured up to 28 days post IMP administration on Day 1 of Cycle 1 or the day before Cycle 3 Day 1, whichever comes earlier (each cycle is 14 days)
Occurrence of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs)
measured from first IMP administration up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
Occurrence of dose interruption or discontinuation of study treatment due to TEAEs
measured from first IMP administration up to 14 days after the last dose of IMP
MTD or the recommended phase two dose (RP2D) of BNT317
measured For MTD, up to 28 days post IMP administration on Cycle 1 Day 1 or the day before Cycle 3 Day 1, whichever comes earlier (each cycle is 14 days) or, for RP2D, up to 100 days
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