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 now · Phase 1/Phase 2
Conditions studied: Advanced Solid Tumor
In brief
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.
Key facts
- Study ID
- NCT07070232
- Run by
- BioNTech SE
- People needed
- 1438
- Starts
- 2025-08-12
- Expected to finish
- 2030-03-01
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
- Centre hospitalier universitaire de Liège — Liège, Belgium (enrolling)
- Yale University — New Haven, Connecticut, United States (enrolling)
- Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
- Universitair Ziekenhuis Gent — Ghent, Belgium (enrolling)
- Hartford Healthcare — Hartford, Connecticut, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Brigitte Harris Cancer Pavilion BHCP — Detroit, Michigan, United States (enrolling)
- START Midwest, LLC — Grand Rapids, Michigan, United States (enrolling)
- Memorial Sloan Kettering Hospital — New York, New York, United States (enrolling)
- One Clinical Research Pty Ltd — Nedlands, Western Australia, Australia (enrolling)
- Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States (enrolling)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- South Texas Accelerated Research Therapeutics (START), LLC — San Antonio, Texas, United States (enrolling)
- START Mountain Region — West Valley City, Utah, United States (enrolling)
- The Board of Regents of the University of Wisconsin — Madison, Wisconsin, United States (enrolling)
- Blacktown Hospital — Blacktown, New South Wales, Australia (enrolling)
- St Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia (enrolling)
- Melanoma Institute Australia — Wollstonecraft, New South Wales, Australia (enrolling)
- Tasman Oncology Research Ltd — Southport, Queensland, Australia (enrolling)
- Cancer Research SA — Adelaide, South Australia, Australia (enrolling)
- Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
- Austin Health — Heidelberg, Victoria, Australia (enrolling)
- Ziekenhuis Aan de Stroom ZAS vzw — Wilrijk, Belgium (enrolling)
Full record on ClinicalTrials.gov
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