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RECRUITING
NCT07255404
PHASE2

A Clinical Trial Testing the Safety of BNT327 (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic Cancer

Sponsor: BioNTech SE

View on ClinicalTrials.gov

Summary

This study will enroll adults with confirmed metastatic pancreatic ductal adenocarcinoma (PDAC, systemic PDAC treatment naïve), Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1, and adequate organ function. Participants will receive pumitamig (BNT327) in combination with chemotherapy.

Official title: A Phase II, Multi-site, Randomized, Open-label, Trial of BNT327 in Combination With Chemotherapy in Patients With Metastatic Pancreatic Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2025-12-04

Completion Date

2028-08

Last Updated

2026-04-29

Healthy Volunteers

No

Interventions

DRUG

Pumitamig

Intravenous (IV) infusion

DRUG

Nab-paclitaxel

IV infusion

DRUG

Gemcitabine

IV infusion

DRUG

mFOLFIRINOX

IV infusion

Locations (10)

Tsinghua Changgung Hospital

Beijing, China

Sichuan Cancer Hospital

Chengdu, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China

Zhejiang Provincial People's Hospital

Hangzhou, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

The Affiliated Cancer Hospital of Guangxi Medical University

Nanning, China

Huashan Hospital, Fudan University

Shanghai, China

Fudan University Shanghai Cancer Center

Shanghai, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Henan Cancer Hospital

Zhengzhou, China