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RECRUITING
NCT07255404
PHASE2

A Clinical Trial Testing the Safety of Pumitamig (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 (also known as BNT327, BMS-986545, or PM8002) in combination with chemotherapy.

Official title: A Phase II, Multi-site, Randomized, Open-label, Trial of Pumitamig 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

2026-07-28

Healthy Volunteers

No

Interventions

DRUG

Pumitamig

Intravenous (IV) infusion

DRUG

Nab-paclitaxel

IV infusion

DRUG

Gemcitabine

IV infusion

DRUG

mFOLFIRINOX

IV infusion

Locations (24)

Flinder's Medical Centre

Bedford Park, Australia

Pindara Private Hospital

Benowa, Australia

Peninsula & South Eastern Haematology and Oncology Group

Frankston, Australia

The Alfred Hospital

Melbourne, Australia

St Vincent's Hospital

Melbourne, Australia

One Clinical Research

Mount Pleasant, Australia

GenesisCare

Saint Leonards, Australia

Sunshine Coast Private Hospital

Sunshine Coast, Australia

Westmead Hospital

Sydney, Australia

Tsinghua Changgung Hospital

Beijing, China

Jilin Cancer Hospital

Changchun, China

Sichuan Cancer Hospital

Chengdu, China

Zhongshan Hospital Affiliated with Dalian University

Dalian, China

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

Guangzhou, China

Zhejiang Provincial People's Hospital

Hangzhou, China

Shandong University Cancer Hospital

Jinan, China

Yunnan Cancer Hospital

Kunming, 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

The First Affiliated Hospital of China Medical University

Shenyang, China

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

Wuhan, China

Henan Cancer Hospital

Zhengzhou, China