Clinical Trial

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

Recruiting Phase 1/2
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Summary
The aim of this first-in-human (FIH) open-label, multi-site study is to evaluate safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary clinical efficacy of BNT3212, including identification of the recommended dose of BNT3212 for use as monotherapy and with pumitamig (also known as BNT327 or PM8002) as combination therapy, in adults with advanced solid tumors who have exhausted other treatment options.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-08-22; most recent amendment 2026-06-12.
Status change: Not Yet Recruiting → Recruiting 2025-09-25
Trial Details
NCT Number NCT07147348
Lead Sponsor BioNTech SE
Collaborators: Biotheus (Hengqin) Co., Ltd., BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Conditions Advanced Solid Tumor
Enrollment 375 participants
Start Date 2025-08-27
Primary Completion 2027-11 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-06-15