Actively Recruiting
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
Led by BioNTech SE · Updated on 2026-05-13
245
Participants Needed
10
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Have an ECOG performance status of 0 to 1
- Have measurable disease per RECIST 1.1 or Gynecologic Cancer InterGroup criteria for ovarian cancer
- Have a life expectancy of at least 3 months as judged by the investigator
- Have adequate organ, coagulation, and blood function as defined in the protocol
- For Parts A, B, and C: Have a confirmed advanced or metastatic tumor known to express CA19-9, including pancreatic ductal adenocarcinoma, bile duct carcinoma, invasive urothelial carcinoma of bladder and urinary tract, colorectal adenocarcinoma, esophagogastric junction adenocarcinoma, endometrial carcinoma, or epithelial ovarian cancer
- For Parts A, B, and C: Have no standard treatment likely to provide clinical benefit and have failed at least first-line standard therapy
- For Part D: Have confirmed pancreatic ductal adenocarcinoma
- For Part D: Have received at least one prior systemic treatment for advanced or metastatic disease
- For Part D: Have radiographic disease progression and no standard treatment likely to provide benefit
You will not qualify if you...
- Are currently enrolled in another investigational study or subject to exclusion periods from such studies
- Have not completed the required washout period from prior anticancer treatments before the first dose
- Have received systemic steroids over 10 mg/day prednisone or equivalent, or other immunosuppressive therapy within 2 weeks prior to first dose (exceptions include inhaled, topical, local steroids, physiological replacement, or pre-medication for hypersensitivity)
- Have received any live vaccine within 4 weeks prior to first dose or plan to receive one during the study
- Have brain metastases or spinal cord compression unless stable and off steroids and anticonvulsants for at least 2 weeks before first dose
- Have a history or current diagnosis of interstitial lung disease or pneumonitis requiring steroids or unable to rule out suspected disease by imaging
- Have active gastric or duodenal ulcers, ulcerative colitis, or other gastrointestinal conditions that may cause bleeding or perforation
- Have an active infection requiring systemic therapy within 1 week prior to first dose (those on prophylactic anti-infective therapy may be eligible)
- Have unresolved toxicities from previous anticancer treatments as defined in the protocol
AI-Screening
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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
CONTACT
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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