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
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.
Description
The study will consist of up to four parts (Parts A, B, C, and D). Parts A, B, and C will be a dose escalation to investigate the safety and tolerability of BNT329. Parts A, B, and C will enroll participants with the following advanced solid tumors known to express carbohydrate antigen 19-9 (CA19-9): pancreatic ductal adenocarcinoma (PDAC) (the most common type of pancreatic cancer), bile duct cancer, a certain type of bladder cancer that started in the lining of the bladder or urinary tract (invasive urothelial carcinoma of the bladder and urinary tract), colorectal cancer, gastroesophageal…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria All participants and parts: * Have an ECOG PS of 0 to 1 * Have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), except for ovarian cancer where participants will be evaluated according to Gynecologic Cancer InterGroup criteria. * Have a life expectancy of ≥3 months in the opinion of the investigator. * Have adequate organ, coagulation, and hematologic function as defined in the protocol. Parts A, B, and C: * Have a histologically confirmed advanced/metastatic tumor type that is known to express CA19-9: PDAC, carcinoma of t…
Interventions
- DrugBNT329
Intravenous (IV) infusion
- DrugCA19-9-targeting monoclonal antibody
Monoclonal antibody
Locations (8)
- Florida Cancer SpecialistsOrlando, Florida
- Memorial Sloan Kettering Cancer CenterNew York, New York
- St. Josef-Hospital im Katholischen Klinikum BochumBochum
- Hospital San PedroLogroño
- Hospital Universitario HM Sanchinarro - START Madrid CIOCCMadrid
- Hospital Universitario Quironsalud Madrid - NEXT OncologyPozuelo de Alarcón