Pumitamig combined with chemotherapy for people with untreated metastatic pancreatic cancer
Official title: A Phase II, Multi-site, Randomized, Open-label, Trial of Pumitamig in Combination With Chemotherapy in Patients With Metastatic Pancreatic Cancer
Run by BioNTech SE · NCT07255404 · Data updated 2026-11-12
This trial will test whether adding pumitamig (BNT327) to standard chemotherapy helps people with newly diagnosed metastatic pancreatic ductal adenocarcinoma who have not yet had systemic treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 105 (estimated) |
| Sponsor | BioNTech SE Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, prednisone |
| Locations | 24 sites (Bedford Park and 23 other locations) |
| Status | Recruiting |
| Started | December 4, 2025 |
| Main results expected | December 2027 |
| Study ends | August 2028 |
| Registry record updated | July 28, 2026 |
| Trial ID | NCT07255404 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with histologically or cytologically confirmed metastatic PDAC who are systemic treatment‑naive for metastatic disease, have ECOG 0–1, adequate organ function, and at least one measurable lesion.
✕Probably not a fit
Patients who have already received prior systemic therapy for metastatic PDAC, have poor performance status (ECOG >1), or have uncontrolled comorbidities are unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with confirmed, treatment‑naive metastatic pancreatic ductal adenocarcinoma and ECOG performance status 0–1 will receive pumitamig together with a physician‑chosen chemotherapy backbone (mFOLFIRINOX or nab‑paclitaxel plus gemcitabine). Participants assigned to mFOLFIRINOX are randomized 1:1 between two mFOLFIRINOX arms, and once initial enrollment completes, exploratory cohorts will open. The study includes a screening period up to 28 days, treatment for up to 2 years, a 90‑day safety follow‑up after the last dose, and long‑term survival follow‑up. Tumor response is measured using RECIST v1.1 and safety is monitored throughout.
Why it matters
Potential benefit: If successful, adding pumitamig could increase tumor response and potentially extend survival for people with metastatic PDAC.
How similar studies have gone: Immune therapies have shown limited benefit so far in pancreatic cancer, and bispecific antibodies are a newer, early‑stage approach with only limited clinical evidence to date.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Have a histologically or cytologically confirmed metastatic PDAC. A tissue sample, archival or fresh, must be provided during the screening period, unless biopsy is not feasible due to safety concerns. * Have not received prior systemic therapy for unresectable metastatic PDAC. For participants who have received prior induction chemotherapy, concurrent chemoradiotherapy, or adjuvant/neoadjuvant chemotherapy for curative-intent, the interval should be at least 6 months from the end of the last treatment to relapse. * Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures) are not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system \[CNS\] metastasis should not be considered as a measurable lesion). * Agree to discontinue strong inhibitors or inducers of cytochrome P450 enzyme (CYP3A), CYP2C8, glucuronosyltransferase 1 family, polypeptide A cluster 1A (UGT1A1) at least 2 weeks prior to starting study treatment, and change to other treatment regimens at screening if such drugs are used. Key Exclusion Criteria: * Have received any of the following therapies or drugs before study enrollment: * Have received prior systemic anticancer therapy for unresectable metastasis disease. Prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed, provided it has been completed more than 6 months prior to the first dose of study treatment * Any immunostimulatory, or immunosuppressive treatment within 4 weeks (or five half-lives, whichever is longer) before starting study treatment. * PD(L)-1/VEGF bispecific antibody, including monotherapy with either category or combinations thereof. * Systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 14 days before starting study treatment. Exception: Excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergies) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens). * Vaccinations with live attenuated vaccine(s) within 4 weeks before starting study treatment. * Any non-study investigational medicinal product within five half-lives of the first dose or within 4 weeks, whichever is longer, before initiation of study treatment in this study or ongoing participation in the active treatment phase of another interventional clinical study. * Have undergone major organ surgery (core needle biopsies are allowed \>7 days before starting study treatment), open biopsy, significant trauma, or invasive dental procedures (such as dental implants) within 28 days before starting study treatment, or a planned/anticipated need for major surgery during the study treatment period. Placement of vascular infusion devices is allowed. Note: If participant has had major surgery, they must have recovered adequately from the toxicity and/or complications from the treatment before starting study treatment. * Have received allogeneic hematopoietic stem cell transplantation or organ transplantation. * Have spinal cord compression or CNS metastases that are untreated and symptomatic or require treatment with corticosteroids or anticonvulsants for associated-symptom control. Exception: Treated brain metastases which are no longer symptomatic and for which no corticosteroid or anticonvulsant treatment is needed (the participant must have recovered from the acute toxic effect of radiotherapy). * Have active autoimmune disease or history of autoimmune diseases with anticipated relapse (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for those with clinically stable autoimmune thyroid disease or type 1 diabetes mellitus. * Have had other malignant tumors within 5 years before starting study treatment. Exception: Those who have been cured with local treatment (such as basal cell or squamous-cell carcinoma of the skin, superficial or noninvasive bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary carcinoma of thyroid and early-stage prostate cancer). * Have heart conditions as specified in the protocol within 6 months before starting study treatment. * History of myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular accident within 6 months before starting study treatment. * History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 3 months prior to randomization, unless the participant has been fully treated (e.g., inferior vena cava filter placed) and/or adequately anticoagulated on a prophylactic dose. * Have serious or non-healing wounds, ulcers, or (incompletely healed) bone fractures. This includes history (within 6 months before starting the study treatment) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices, or acute gastrointestinal bleeding. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation. * Have significant risk of hemorrhage (in the opinion of the investigator) or evidence of major coagulation disorders as specified in the protocol. * Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Those with indwelling catheters (e.g., PleurX) are allowed. * Participants with a history of serious Grade 3 or higher immune-related adverse events (irAEs) that led to treatment discontinuation of a prior immunotherapy. Participants with a history of Grade 3 or higher irAEs that did not lead to treatment discontinuation of a prior immunotherapy may be enrolled at the investigator's discretion. * Have adverse events (AEs) from prior antitumor therapy that have not returned to Grade 1 (graded by CTCAE v5.0 criteria) or below (unless the investigator determines that certain AEs pose no safety risk to participants, such as hair loss, or stable hypothyroidism under hormone replacement therapy). * Have gastrointestinal symptoms or conditions as specified in the protocol. * Have a known or suspected hypersensitivity to the study treatments including any active ingredient or excipients thereof. * Have superior vena cava syndrome or symptoms of spinal cord compression. * Have active, or a history of, pneumonitis requiring treatment with steroids, or have active or a history of interstitial lung disease. Those with a history of pulmonary fibrosis or with currently diagnosed severe lung diseases such as interstitial pneumonia, pneumoconiosis, chemical pneumonitis, or any other condition resulting in significant impairment in lung function. Exception: Asymptomatic interstitial changes caused by previous radiotherapy, chemotherapy, or other factors such as smoking are allowed. * Have active infection (e.g., bacterial or fungal infections or tuberculosis) requiring systemic treatment or any uncontrolled infection within 14 days prior to the first dose of study treatment. * Have active syphilis. Participants with inactive previous infection could be eligible: Infection with a positive non-specific antibody test for syphilis (e.g., TRUST \[Toluidine Red Unheated Serum Test\], Rapid Plasma Reagin \[RPR\], TP-PA \[Treponema pallidum Particle Agglutination\]) or have a positive syphilis-specific antibody test (e.g., TPPA) (a positive "syphilis-specific antibody test" but a negative "non-specific antibody test for syphilis" for more than 1 year) infection. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Where it's running
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Peninsula & South Eastern Haematology and Oncology Group
Frankston, Australia Recruiting -
GenesisCare
Saint Leonards, Australia Recruiting -
Tsinghua Changgung Hospital
Beijing, China Recruiting -
Sichuan Cancer Hospital
Chengdu, China Recruiting -
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China Recruiting -
Zhejiang Provincial People's Hospital
Hangzhou, China Recruiting
Show 18 more locations
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Yunnan Cancer Hospital
Kunming, China Recruiting -
The First Affiliated Hospital of Nanchang University
Nanchang, China Recruiting -
The Affiliated Cancer Hospital of Guangxi Medical University
Nanning, China Recruiting -
Huashan Hospital, Fudan University
Shanghai, China Recruiting -
Fudan University Shanghai Cancer Center
Shanghai, China Recruiting -
The First Affiliated Hospital of China Medical University
Shenyang, China Recruiting -
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China Recruiting -
Henan Cancer Hospital
Zhengzhou, China Recruiting -
Flinder's Medical Centre
Bedford Park, Australia Not yet recruiting -
Pindara Private Hospital
Benowa, Australia Not yet recruiting -
The Alfred Hospital
Melbourne, Australia Not yet recruiting -
St Vincent's Hospital
Melbourne, Australia Not yet recruiting -
One Clinical Research
Mount Pleasant, Australia Not yet recruiting -
Sunshine Coast Private Hospital
Sunshine Coast, Australia Not yet recruiting -
Westmead Hospital
Sydney, Australia Not yet recruiting -
Jilin Cancer Hospital
Changchun, China Not yet recruiting -
Zhongshan Hospital Affiliated with Dalian University
Dalian, China Not yet recruiting -
Shandong University Cancer Hospital
Jinan, China Not yet recruiting
Study contacts
- Study coordinator: BioNTech clinical trials patient information
- Email: patients@biontech.de
- Phone: +49 6131 9084
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.