Clinical Trial

Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors

Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
This study is the first time the drug BNT3214 (also referred to as PM8102) will be tested in people. It is designed to find out if the drug is safe and how well it works for adults with advanced solid tumors. The study will have three parts. The first two parts (Parts A and B) will focus on testing different amounts of BNT3214 to figure out the best and safest dose. The third part (Part C) will test selected doses of BNT3214 in multiple types of cancer.
Protocol Amendment History 3 changes
notable Trial sites expanded: 5 -> 16 locations 2026-07-10
critical Recruitment opened 2026-04-02
notable Trial sites expanded: 0 -> 4 locations 2026-04-02
Trial Details
NCT Number NCT07455734
Lead Sponsor BioNTech SE
Collaborators: BioNTech (Shanghai) Pharmaceuticals Co., Ltd., Biotheus (Hengqin) Co., Ltd.
Conditions Advanced Solid Tumor Cancer
Enrollment 533 participants
Start Date 2026-03-30
Primary Completion 2030-10 (estimated)
Study Completion 2030-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-13