Clinical Trial

A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors

Recruiting Phase 1/2
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Summary
This study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with immunotherapeutic agents (Part 2) in participants with histologically or cytologically confirmed solid tumors that are advanced (i.e., either metastatic or recurrent tumors with no further definitive treatment possible) and/or have relapsed/progressed after prior therapy.
Protocol Amendment History 5 changes
notable Enrollment increased: 980 -> 1438 participants 2026-07-23
minor Trial arms changed: 16 -> 18 2026-07-23
notable Trial sites expanded: 64 -> 67 locations 2026-07-23
minor Completion pushed: 2029-10 -> 2030-03 2026-07-23
notable Trial sites expanded: 53 -> 64 locations 2026-05-23
Trial Details
NCT Number NCT07070232
Lead Sponsor BioNTech SE
Collaborators: BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Conditions Advanced Solid Tumor
Enrollment 1,438 participants
Start Date 2025-08-12
Primary Completion 2028-03 (estimated)
Study Completion 2030-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-22