RecruitingPhase 1Phase 2NCT07186842

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


Sponsor

BioNTech SE

Enrollment

245 participants

Start Date

Nov 18, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental cancer drug called BNT329 in people with advanced solid tumors that produce a protein called CA19-9 (found in pancreatic cancer, bile duct cancer, bladder cancer, colorectal cancer, ovarian cancer, and esophageal cancer). The goal is to assess safety and early signs of effectiveness. **You may be eligible if...** - You have a confirmed advanced or metastatic tumor that is known to express the CA19-9 protein - Your cancer has progressed on standard treatments and no other standard options are available - Your overall health is reasonably good (ECOG performance status 0–1) - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - Standard treatment options are still available that could help you - You have poor organ function or low blood counts - You have not yet received all available standard treatments for your cancer type Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBNT329

Intravenous (IV) infusion

DRUGCA19-9-targeting monoclonal antibody

Monoclonal antibody


Locations(8)

Florida Cancer Specialists

Orlando, Florida, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

St. Josef-Hospital im Katholischen Klinikum Bochum

Bochum, Germany

Hospital San Pedro

Logroño, Spain

Hospital Universitario HM Sanchinarro - START Madrid CIOCC

Madrid, Spain

Hospital Universitario Quironsalud Madrid - NEXT Oncology

Pozuelo de Alarcón, Spain

Northern Centre for Cancer Research

Newcastle upon Tyne, United Kingdom

The Royal Marsden Hospital

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07186842


Related Trials