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

Inclusion Criteria:

• Have a histologically or cytologically confirmed metastatic PDAC. A tissue sample,archival or fresh, must be provided during the screening period. In case it is notfeasible to meet the required tumor tissue criteria, approval by the sponsor'smedical monitor is needed for enrollment.

• Have not received prior systemic therapy for unresectable metastatic PDAC. Forparticipants who have received prior induction chemotherapy, concurrentchemoradiotherapy, or adjuvant/neoadjuvant chemotherapy for curative-intent, theinterval 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, interventionalprocedures) are not considered as target lesions. If the lesion with prior localtreatment is the only targeted lesion, evidence-based radiology must be provided todemonstrate disease progression (the single bone metastasis or the single centralnervous 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 treatmentregimens at screening if such drugs are used.

Exclusion Criteria:

• Have received any of the following therapies or drugs before study enrollment:

• Have received prior systemic anticancer therapy for unresectable metastasisdisease.

• Any anticancer therapy, including systemic, palliative, biologic,immunostimulatory, or immunosuppressive treatment within 4 weeks (or fivehalf-lives, whichever is longer) before starting study treatment.

• PD(L)-1/VEGF bispecific antibody, including monotherapy with either category orcombinations thereof.

• Systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone oran equivalent dose of other corticosteroids) within 14 days before startingstudy treatment. Exception: Excluding local, intranasal, intraocular,intra-articular or inhaled corticosteroids, short-term use (≤7 days) ofcorticosteroids for prophylaxis (e.g., prevention of contrast agent allergies)or treatment of non-autoimmune conditions (e.g., delayed hypersensitivityreactions caused by exposure to allergens).

• Vaccinations with live attenuated vaccine(s) within 4 weeks before startingstudy treatment.

• Broad-spectrum intravenous antibiotics therapy within 2 weeks before startingstudy treatment.

• Any non-study investigational medicinal product within five half-lives of thefirst dose or within 4 weeks, whichever is longer, before initiation of studytreatment in this study or ongoing participation in the active treatment phaseof another interventional clinical study.

• Antiplatelet drugs, such as aspirin (>325 mg/day), clopidogrel (>75 mg/day),dipyridamole, ticlopidine or cilostazol, etc., within 10 days before startingstudy treatment to avoid inclusion of participants who have used plateletaggregation inhibitors before the study.

• Have undergone major organ surgery (core needle biopsies are allowed >7 days beforestarting study treatment), open biopsy, significant trauma, or invasive dentalprocedures (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 hadmajor surgery, they must have recovered adequately from the toxicity and/orcomplications from the treatment before starting study treatment.

• Have received allogeneic hematopoietic stem cell transplantation or organtransplantation.

• Have spinal cord compression or CNS metastases that are untreated and symptomatic orrequire treatment with corticosteroids or anticonvulsants for associated-symptomcontrol. Exception: Treated brain metastases which are no longer symptomatic and forwhich no corticosteroid or anticonvulsant treatment is needed (the participant musthave recovered from the acute toxic effect of radiotherapy).

• Have active autoimmune disease or history of autoimmune diseases with anticipatedrelapse (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis,etc.), except for those with clinically stable autoimmune thyroid disease or type 1diabetes 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 orsquamous-cell carcinoma of the skin, superficial or noninvasive bladder cancer,carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, andpapillary carcinoma of thyroid and early-stage prostate cancer).

• Have heart conditions as specified in the protocol within 6 months before startingstudy treatment.

• Have uncontrolled hypertension or poorly controlled diabetic conditions as specifiedin the protocol before starting study treatment.

• History of myocardial infarction, unstable angina, arterial thrombosis orcerebrovascular accident within 6 months before starting study treatment.

• History of deep vein thrombosis, pulmonary embolism, or any other significantthromboembolism within 3 months prior to randomization, unless the participant hasbeen fully treated (e.g., inferior vena cava filter placed) and/or adequatelyanticoagulated 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 riskof abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, orintra-abdominal abscess or esophageal and gastric varices, or acute gastrointestinalbleeding. In addition, the participant must have undergone correction (orspontaneous healing) of the perforation/fistula and/or the underlying processcausing the fistula/perforation.

• Have significant risk of hemorrhage (in the opinion of the investigator) or evidenceof major coagulation disorders as specified in the protocol.

• Have uncontrolled pleural effusion, pericardial effusion, or ascites requiringrecurrent drainage procedures (once monthly or more frequently). Those withindwelling catheters (e.g., PleurX) are allowed.

• Participants with a history of serious Grade 3 or higher immune-related adverseevents (irAEs) that led to treatment discontinuation of a prior immunotherapy.Participants with a history of Grade 3 or higher irAEs that did not lead totreatment discontinuation of a prior immunotherapy may be enrolled at theinvestigator's discretion.

• Have adverse events (AEs) from prior antitumor therapy that have not returned toGrade 1 (graded by CTCAE v5.0 criteria) or below (unless the investigator determinesthat certain AEs pose no safety risk to participants, such as hair loss, Grade 2peripheral neuropathy or stable hypothyroidism under hormone replacement therapy).

• Have gastrointestinal symptoms or conditions as specified in the protocol.

• History of serious allergic diseases, history of serious allergy to drugs (includingunlisted investigational drug) or known allergy or intolerance to any ingredient ofthe study treatment.

• Have superior vena cava syndrome or symptoms of spinal cord compression.

• Have active, or a history of, pneumonitis requiring treatment with steroids, or haveactive or a history of interstitial lung disease. Those with a history of pulmonaryfibrosis or with currently diagnosed severe lung diseases such as interstitialpneumonia, pneumoconiosis, chemical pneumonitis, or any other condition resulting insignificant impairment in lung function. Exception: Asymptomatic interstitialchanges caused by previous radiotherapy, chemotherapy, or other factors such assmoking are allowed.

• Have a known history of tuberculosis that was not successfully treated.

• Have active syphilis. Participants with inactive previous infection could beeligible: 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-specificantibody test (e.g., TPPA) (a positive "syphilis-specific antibody test" but anegative "non-specific antibody test for syphilis" for more than 1 year) infection.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.