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RECRUITING
NCT07186842
PHASE1/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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

245

Start Date

2025-11-18

Completion Date

2030-05

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

DRUG

BNT329

Intravenous (IV) infusion

DRUG

CA19-9-targeting monoclonal antibody

Monoclonal antibody

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