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OncoMatch/Clinical Trials/NCT07255404

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

Is NCT07255404 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pumitamig and Nab-paclitaxel for pancreatic ductal adenocarcinoma (pdac).

Phase 2RecruitingBioNTech SENCT07255404Data as of May 2026

Treatment: Pumitamig · Nab-paclitaxel · Gemcitabine · mFOLFIRINOXThis 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.

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Disease stage

Required: Stage IV

Metastatic disease required

Have a histologically or cytologically confirmed metastatic PDAC. Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic anticancer therapy

Exception: adjuvant/neoadjuvant/induction/concurrent chemoradiotherapy for curative-intent completed ≥ 6 months before relapse

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.

Cannot have received: systemic, palliative, biologic, immunostimulatory, or immunosuppressive treatment

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

Cannot have received: PD(L)-1/VEGF bispecific antibody

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

Cannot have received: systemic corticosteroids

Exception: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (≤7 days) for prophylaxis or non-autoimmune conditions

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.

Cannot have received: live attenuated vaccine

Vaccinations with live attenuated vaccine(s) within 4 weeks before starting study treatment.

Cannot have received: broad-spectrum intravenous antibiotics

Broad-spectrum intravenous antibiotics therapy within 2 weeks before starting study treatment.

Cannot have received: non-study investigational medicinal product

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.

Cannot have received: antiplatelet drugs (aspirin (>325 mg/day), clopidogrel (>75 mg/day), dipyridamole, ticlopidine, cilostazol)

Antiplatelet drugs, such as aspirin (>325 mg/day), clopidogrel (>75 mg/day), dipyridamole, ticlopidine or cilostazol, etc., within 10 days before starting study treatment

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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