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
NCT07255404 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105
Last updated 2026-04-29
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.
Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
Interventions
- DRUG
-
Pumitamig
Intravenous (IV) infusion
- DRUG
-
IV infusion
- DRUG
-
IV infusion
- DRUG
-
mFOLFIRINOX
IV infusion
Sponsors & Collaborators
- collaborator INDUSTRY
-
BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
BioNTech Responsible Person · BioNTech SE
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-04
- Primary Completion
- 2027-12-31
- Completion
- 2028-08-31
Countries
- China
Study Locations
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