Actively Recruiting
First-in-human Open-label Dose Escalation Trial to Evaluate Safety and Preliminary Efficacy of BNT329 in Advanced Solid Tumors Expressing CA19-9
Led by BioNTech SE · Updated on 2026-05-13
245
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of an investigational drug called BNT329 in people with advanced solid tumors that express a tumor marker known as CA19-9. The study aims to find the best dose of BNT329 by monitoring side effects and their severity. It also seeks to understand how well BNT329 works by measuring the number of participants who respond to treatment and how long their tumor remains stable without growing or spreading. Additionally, the study will examine how BNT329 moves through and affects the body. The trial includes up to four parts. Parts A, B, and C focus on finding safe dose levels through dose escalation in participants with various advanced cancers expressing CA19-9, including pancreatic, bile duct, bladder, colorectal, gastroesophageal, endometrial, and ovarian cancers. Part B tests a more frequent dosing schedule, and Part C tests pre-dosing with a CA19-9 targeting monoclonal antibody before BNT329. Part D is a dose optimization and proof-of-concept phase for participants with pancreatic cancer who have received prior treatments. Treatments are given as intravenous infusions every two to three weeks, with participants in Part D randomized to receive one of two doses. Participants will undergo a screening period followed by treatment lasting up to two years. After treatment, there will be an end-of-treatment visit, two safety follow-up visits, and ongoing survival follow-up until death, withdrawal, or study end. Researchers will monitor side effects, treatment responses, and how the drug is processed in the body through clinical assessments and laboratory tests. The study can last up to about three years for some outcomes, including tumor response and safety evaluations.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status of 0 to 1
- Measurable disease per RECIST 1.1 or appropriate criteria for ovarian cancer
- Life expectancy of at least 3 months as judged by the investigator
- Adequate organ, coagulation, and blood function
- For Parts A, B, and C: Histologically confirmed advanced/metastatic tumor expressing CA19-9, including pancreatic, bile duct, bladder, colorectal, gastroesophageal, endometrial, or ovarian cancers
- No standard therapy likely to benefit, having received all available standard treatments including targeted therapies and failed at least first-line therapy
- For Part D: Histologically confirmed pancreatic ductal adenocarcinoma
- Received at least one prior systemic treatment for advanced/metastatic disease
- Radiographic disease progression and no standard therapy likely to benefit
You will not qualify if you...
- Participation in another investigational study or within exclusion periods from such studies
- Inadequate washout period from prior anticancer treatments
- Use of systemic steroids over 10 mg/day prednisone or equivalent within 2 weeks prior to first dose, except certain inhaled, topical, or physiological replacement steroids
- Receipt of live vaccine within 4 weeks prior to first dose or planned during the study
- Brain metastases or spinal cord compression unless stable and off steroids and anticonvulsants for at least 2 weeks
- History or current interstitial lung disease/pneumonitis requiring steroids or suspected but not ruled out
- Active gastrointestinal ulcers or conditions that may cause bleeding or perforation
- Active infection requiring systemic therapy within 1 week prior to first dose
- Unresolved toxicities from previous anticancer therapy
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive the investigational drug BNT329, administered intravenously at protocol-defined dose levels. Some participants may receive pre-dosing with a CA19-9 targeting monoclonal antibody before BNT329 administration. Treatment schedules vary from once every 3 weeks to once every 2 weeks depending on the study part and randomization.
Visits every 2 to 3 weeks during treatment period
Duration - Single day
A visit to assess participant status at the end of the treatment period.
1 visit (in-person)
Duration - Up to 60 days after last dose of BNT329
Participants are monitored for adverse events and safety outcomes after treatment ends.
2 follow-up visits
Duration - Up to approximately 36 months
Participants are followed until death, withdrawal of consent, or study termination to collect survival data.
Visits as needed for survival status
Trial Site Locations
Total: 10 locations
1
Florida Cancer Specialists
Orlando, Florida, United States, 32827
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
3
St. Josef-Hospital im Katholischen Klinikum Bochum
Bochum, Germany, 44791
Actively Recruiting
4
Universitaetsklinikum Ulm
Ulm, Germany, D-89081
Actively Recruiting
5
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
6
Hospital San Pedro
Logroño, Spain, 26006
Actively Recruiting
7
Hospital Universitario HM Sanchinarro - START Madrid CIOCC
Madrid, Spain, 28050
Actively Recruiting
8
Hospital Universitario Quironsalud Madrid - NEXT Oncology
Pozuelo de Alarcón, Spain, 28223
Actively Recruiting
9
Northern Centre for Cancer Research
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
10
The Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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