A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9
← catalyst calendarNCT07186842 · readout ≤ 1,381 d
Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
245estimated
Sites
16
Countries
Australia, Germany, Spain +2
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 | 2025-11-18 | actual | When the study began enrolling |
| Primary completion | May 2030 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | May 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2025-09-22 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-17 | 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 Cancers
Interventions
- Drug: BNT329
- Drug: CA19-9-targeting monoclonal antibody
Primary outcomes
what the primary-completion date above is the date OFParts A and B - Occurrence of dose-limiting toxicities within a participant
measured First 21 days (Part A) or 28 days (Part B) after the first dose of BNT329.
Parts A, B, and D - Occurrence of treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), treatment-related TEAEs, treatment-related Grade ≥3 TEAEs, and treatment-related SAEs
measured From first dose of BNT329 until 60 days after the last dose of BNT329 (up to 26 months).
Parts A, B, and D - Occurrence of dose interruptions, reductions, and discontinuation of BNT329 due to TEAEs
measured From the time of initiation of the first dose of BNT329 until 60 days after the last dose of BNT329 (up to 26 months).
Part D - Objective response rate (ORR)
measured From first dose of BNT329 until end of study (up to approximately 36 months).
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