A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors
← catalyst calendarNCT07147348 · readout ≤ 468 d
Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →. With Biotheus (Hengqin) Co., Ltd., BioNTech (Shanghai) Pharmaceuticals Co., Ltd..
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
375estimated
Sites
17
Countries
Australia, China
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 | 2025-08-27 | actual | When the study began enrolling |
| Primary completion | Nov 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2025-08-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-15 | 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: BNT3212
- Biological: Pumitamig — also filed as PM8002, BNT327
Primary outcomes
what the primary-completion date above is the date OFParts A and C - Occurrence of dose limiting toxicities (DLTs) within a participant during the DLT observation period
measured Up to 28 days after first dose of investigational medicinal product (IMP).
All parts - Percentage of participants with treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs by relationship
measured From the time of the first dose of IMP until 90 days after the last dose of IMP, approximately up to 31 months.
Parts A and C - Percentage of participants with dose interruptions or discontinuations of study treatment due to TEAEs
measured From the time of the first until last dose of IMP, approximately up to 31 months.
Parts B and D - Percentage of participants with dose interruptions, reductions or discontinuations of study treatment due to TEAEs
measured From the time of the first until last dose of IMP, approximately up to 31 months.
Parts B and D (expansion cohorts) - Objective response rate (ORR)
measured From first dose of IMP until end of study, approximately up to 31 months.
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