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A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9
Sponsor: BioNTech SE
Summary
The main goal of this study is to evaluate the safety of BNT329 and to identify the best dose of BNT329. This will be done by measuring the number of side effects that participants experience and how severe they are. The second goal of this study is to evaluate how well BNT329 works. This will be done by measuring the number of participants who respond to the treatment. The length of time where the tumor does not grow or spread will also be measured. The study will also evaluate how BNT329 moves into, through, and out of the body and how the treatment affects the body.
Official title: First-in-human, Open-label, Multi-site, Phase I/IIa, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT329 in Participants With Advanced Solid Tumors Known to Express CA19-9
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
245
Start Date
2025-11-18
Completion Date
2030-05
Last Updated
2026-05-13
Healthy Volunteers
No
Conditions
Interventions
BNT329
Intravenous (IV) infusion
CA19-9-targeting monoclonal antibody
Monoclonal antibody
Locations (10)
Florida Cancer Specialists
Orlando, Florida, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
St. Josef-Hospital im Katholischen Klinikum Bochum
Bochum, Germany
Universitaetsklinikum Ulm
Ulm, Germany
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital San Pedro
Logroño, Spain
Hospital Universitario HM Sanchinarro - START Madrid CIOCC
Madrid, Spain
Hospital Universitario Quironsalud Madrid - NEXT Oncology
Pozuelo de Alarcón, Spain
Northern Centre for Cancer Research
Newcastle upon Tyne, United Kingdom
The Royal Marsden Hospital
Sutton, United Kingdom