Actively Recruiting
A Phase II Randomized Trial of BNT327 (Pumitamig) Combined With Chemotherapy in Adults With Metastatic Pancreatic Cancer
Led by BioNTech SE · Updated on 2026-04-29
105
Participants Needed
10
Research Sites
34 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
Researchers are evaluating the use of pumitamig (BNT327) combined with chemotherapy in adults diagnosed with metastatic pancreatic ductal adenocarcinoma (PDAC) who have not yet received systemic treatment for their cancer. Participants must have good general health status and adequate organ function. The study aims to assess the safety and effectiveness of this combination treatment in people with advanced pancreatic cancer, a condition with limited treatment options. Participants will be assigned to one of several treatment groups based on their physician's choice of chemotherapy. These include two groups receiving modified FOLFIRINOX with different doses of pumitamig and one group receiving nab-paclitaxel plus gemcitabine with pumitamig. After enrollment in these main groups, additional exploratory groups may open. The treatment period may last up to two years. The study begins with a screening period of up to 28 days, followed by treatment for up to 24 months. After the last dose, participants will be monitored closely for safety for up to 90 days or until they start other anticancer therapies. Survival follow-up continues until death, withdrawal, loss of contact, or study end. Researchers will evaluate response rates, treatment side effects, disease control, progression, survival, and drug levels in the blood during this time.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma
- No prior systemic therapy for unresectable metastatic PDAC (with exceptions for prior curative treatments completed over 6 months ago)
- At least one measurable lesion based on RECIST v1.1
- Agreement to stop certain enzyme inhibitor medications before starting treatment
- Eastern Cooperative Oncology Group performance status of 0-1
- Adequate organ function as required by the study
You will not qualify if you...
- Prior systemic anticancer therapy for unresectable metastatic disease
- Any anticancer treatment within 4 weeks before starting study treatment
- Use of PD(L)-1/VEGF bispecific antibodies
- Use of systemic corticosteroids above specified doses within 14 days before treatment
- Live vaccines within 4 weeks before treatment
- Recent broad-spectrum intravenous antibiotics within 2 weeks before treatment
- Participation in other investigational drug studies recently
- Use of certain antiplatelet drugs within 10 days before treatment
- Major surgery or invasive procedures within 28 days before treatment
- History of organ or stem cell transplantation
- Untreated or symptomatic CNS metastases or spinal cord compression
- Active or unstable autoimmune diseases except stable thyroid disease or type 1 diabetes
- Other cancers within 5 years except certain early-stage or local cancers
- Recent serious heart conditions, uncontrolled hypertension, or diabetes
- Recent thromboembolic events unless fully treated
- Serious or non-healing wounds, ulcers, or fistulas
- High risk of bleeding or coagulation disorders
- Uncontrolled pleural, pericardial effusions, or ascites requiring frequent drainage
- History of serious immune-related adverse events from prior immunotherapy
- Unresolved adverse events from prior cancer therapy above Grade 1 severity
- Gastrointestinal conditions as specified
- History of serious allergic reactions or allergies to study drug components
- Superior vena cava syndrome or spinal cord compression symptoms
- Active or history of pneumonitis or interstitial lung disease with significant lung impairment
- Untreated or unsuccessfully treated tuberculosis
- Active syphilis infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 2 years
Participants receive pumitamig combined with chemotherapy. Treatment duration varies based on the assigned treatment arm and continues for up to 2 years.
Visit schedule depends on treatment regimen and physician's choice
Duration - Up to 32 months
After the last dose of study treatment, participants are followed for safety monitoring and survival status until death, withdrawal, loss of contact, or study termination.
Visits for safety follow-up up to 90 days after treatment; survival follow-up thereafter
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
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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