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
Start Date
11/18/2025
Completion Date
5/1/2030
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.
Detailed Description
The study will consist of up to four parts (Parts A, B, C, and D). Parts A and B will be a dose escalation to investigate the safety and tolerability of BNT329. Parts A and B 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 junction cancer, gastric adenocarcinoma, endometrial cancer, or ovarian cancer. The cancer must not have responded well to previous treatments. The study will start with recruitment into Part A. Part B (testing a more frequent dosing schedule) will only be opened if indicated by cumulative data from Part A of the study. Part C (testing pre-dosing with a CA19-9 targeting monoclonal antibody prior to BNT329 administration) will only be opened in case of unforeseen safety and/or weak efficacy signals are detected in Part A and (if opened) Part B. Details on Part C will be added in a future update, if it is necessary, to open this part. Part D will be a dose optimization and proof-of-concept study to further investigate the safety and tolerability of BNT329 and to investigate preliminary anti-tumor activity. Part D will enroll participants with second-line plus PDAC. Parts A, B, and C will be non-randomized. In Part D, participants will be randomized (1:1) into one of two arms which will evaluate two dose levels (as selected from Parts A and B). The study consists of a screening period, a treatment period, an end of treatment visit, two safety follow-up visits, and a survival follow-up period. The treatment period will last for a maximum of 2 years. Participants will remain in the survival follow-up until death, withdrawal of participant's consent, or termination of the study, whichever occurs first.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
BNT329
CA19-9-targeting monoclonal antibody
Conditions
Locations
SCRI at HCA Health One
Denver, Colorado 80218
United States
Florida Cancer Specialists
Orlando, Florida 32827
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Monash Health
Clayton, 3168
Australia
Austin Health
Heidelberg, 3084
Australia
St. Josef-Hospital im Katholischen Klinikum Bochum
Bochum, 44791
Germany
Universitaetsklinikum Ulm
Ulm, D-89081
Germany
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Hospital San Pedro
Logroño, 26006
Spain
Hospital Universitario HM Sanchinarro - START Madrid CIOCC
Madrid, 28050
Spain
Hospital Universitario Quironsalud Madrid - NEXT Oncology
Pozuelo de Alarcón, 28223
Spain
St James´s University Hospital
Leeds, LS9 7TF
United Kingdom
Royal Free Hospital
London, NW3 2QG
United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX
United Kingdom
Northern Centre for Cancer Research
Newcastle upon Tyne, NE7 7DN
United Kingdom
The Royal Marsden Hospital
Sutton, SM2 5PT
United Kingdom