RecruitingPhase 2NCT07255404

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

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

Sponsor

BioNTech SE

Enrollment

105 participants

Start Date

Dec 4, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Ductal Adenocarcinoma (PDAC)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called BNT327 — an investigational immunotherapy — combined with standard chemotherapy as a first-line treatment for people with metastatic pancreatic cancer (cancer that has spread beyond the pancreas). The study evaluates how safe and effective this combination is. **You may be eligible if...** - You have been confirmed to have metastatic pancreatic ductal adenocarcinoma (the most common type of pancreatic cancer) - You have not yet received treatment for your metastatic disease - You are able to provide a tumor tissue sample - You meet performance and organ function requirements **You may NOT be eligible if...** - Your cancer is localized (has not spread) - You have active autoimmune disease - You have received prior systemic treatment for metastatic disease - You have significant heart, liver, or lung problems 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.

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Interventions

DRUGPumitamig

Intravenous (IV) infusion

DRUGNab-paclitaxel

IV infusion

DRUGGemcitabine

IV infusion

DRUGmFOLFIRINOX

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

View Full Details on ClinicalTrials.gov

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

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NCT07255404

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