Actively Recruiting
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
Led by BioNTech SE · Updated on 2026-04-29
105
Participants Needed
10
Research Sites
138 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a confirmed metastatic pancreatic ductal adenocarcinoma (PDAC) by tissue sample
- Have not received prior systemic therapy for unresectable metastatic PDAC
- Have at least one measurable tumor lesion based on RECIST v1.1 criteria
- Agree to stop certain CYP enzyme inhibitor or inducer medications at least 2 weeks before treatment
- Have Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1
- Have adequate organ function
You will not qualify if you...
- Received prior systemic anticancer therapy for unresectable metastatic disease
- Received any anticancer therapy within 4 weeks before starting study treatment
- Used PD(L)-1/VEGF bispecific antibodies or systemic corticosteroids above specified doses before treatment
- Had live attenuated vaccines within 4 weeks before starting treatment
- Taken broad-spectrum IV antibiotics within 2 weeks before treatment
- Participated in another investigational drug study recently
- Used antiplatelet drugs above certain doses within 10 days before treatment
- Had major surgery, open biopsy, significant trauma, or invasive dental procedures within 28 days before treatment
- Received hematopoietic stem cell or organ transplantation
- Have untreated symptomatic CNS metastases or spinal cord compression
- Have active or unstable autoimmune diseases except certain stable conditions
- Had other cancers in past 5 years except some localized and treated types
- Have specified heart conditions, uncontrolled hypertension, or poorly controlled diabetes
- Recent history of heart attack, angina, arterial thrombosis, or stroke within 6 months
- Recent blood clots unless fully treated and anticoagulated
- Have serious or non-healing wounds, ulcers, or bone fractures
- Have significant risk of bleeding or major coagulation disorders
- Have uncontrolled fluid buildup requiring frequent drainage
- History of severe immune-related adverse events from prior immunotherapy
- Have unresolved side effects from previous cancer treatments
- Have gastrointestinal symptoms or conditions outlined in the protocol
- History of serious allergies to drugs or components of study treatment
- Have superior vena cava syndrome or spinal cord compression symptoms
- Have active or history of pneumonitis, interstitial lung disease, or severe lung diseases
- Have untreated or unsuccessfully treated tuberculosis
- Have active syphilis infection
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Tsinghua Changgung Hospital
Beijing, China, 102218
Actively Recruiting
2
Sichuan Cancer Hospital
Chengdu, China, 610041
Actively Recruiting
3
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China, 510000
Actively Recruiting
4
Zhejiang Provincial People's Hospital
Hangzhou, China, 325200
Actively Recruiting
5
The First Affiliated Hospital of Nanchang University
Nanchang, China, 330052
Actively Recruiting
6
The Affiliated Cancer Hospital of Guangxi Medical University
Nanning, China, 530200
Actively Recruiting
7
Huashan Hospital, Fudan University
Shanghai, China, 200040
Actively Recruiting
8
Fudan University Shanghai Cancer Center
Shanghai, China, 201318
Actively Recruiting
9
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China, 430030
Actively Recruiting
10
Henan Cancer Hospital
Zhengzhou, China, 450008
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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