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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

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

NCT07186842•BioNTech SE

View on ClinicalTrials.gov

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, 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 junction cancer, 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) and Part C (testing pre-dosing with a CA19-9 targeting monoclonal antibody prior to BNT329 administration) will only be opened if indicated by cumulative data from the study. 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, B, and C). 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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 the bile ducts, invasive urothelial carcinoma of the bladder and urinary tract, colorectal adenocarcinoma, adenocarcinoma of the esophagogastric junction, endometrial carcinoma, and epithelial ovarian cancer (including adenocarcinoma of the fallopian tube and peritoneal epithelial cancer \[except mesothelioma\]).
•Have no available standard of care therapy likely to confer clinical benefit in the opinion of the investigator. Participants must have received all available standard therapies, including targeted therapies based on mutation status (per guidelines from the Food and Drug Administration, American Society of Clinical Oncology, European Society for Medical Oncology, or local guidelines used at the site), and failed at least first-line standard of care therapy prior to enrollment.
•Part D:
•Have a histologically confirmed diagnosis of PDAC.
+2 more criteria

Exclusion Criteria

•All participants and parts:
•Are enrolled in another investigational study or are subject to exclusion periods from another investigational study.
•Have had an inadequate washout period for prior anticancer treatment prior to the first dose of investigational medicinal product (IMP) as defined in the protocol.
•Have received systemic steroids (\>10 mg/day of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks prior to the first dose of IMP. The following are exceptions to this criterion:
•* Inhaled sprays, topical steroids, or local steroid injections (e.g., intra-articular injection).
•* Systemic steroids at physiological doses as replacement therapy (e.g., physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency).
•* Steroids as pre-medication for hypersensitivity reactions (e.g., computed tomography (CT) scan pre-medication).
•Have received any live vaccine within 4 weeks prior to the first dose of IMP or intend to receive a live vaccine during the study.
•Have brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anticonvulsants for at least 2 weeks prior to the first dose of IMP.
•Have a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that requires steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
+3 more criteria

Locations (4)

Florida Cancer Specialists

Orlando, Florida, United States

Hospital Universitario HM Sanchinarro - START Madrid CIOCC

Madrid, Spain

Hospital Universitario Quironsalud Madrid - NEXT Oncology

Pozuelo de Alarcón, Spain

The Royal Marsden Hospital

Sutton, United Kingdom

Key Dates

Start Date

November 18, 2025

Primary Completion Date

May 1, 2030

Completion Date

May 1, 2030

Last Updated

March 13, 2026

Enrollment

245

ESTIMATED participants

Conditions

Advanced Solid Cancers

Interventions

BNT329

DRUG

CA19-9-targeting monoclonal antibody

DRUG

Contacts

BioNTech clinical trials patient information

CONTACT

+49 6131 9084 patients@biontech.de

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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A Study of BMS-863233 in Patients With Advanced and/or Metastatic Solid Tumors

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