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

NCT07255404 | Recruiting Phase 2

• 1 other identifier: BNT327-09
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 10

Brief Summary

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

Pancreatic Ductal Adenocarcinoma (PDAC)

Keywords

PDAC; Bispecific antibody; Metastatic pancreatic cancer; Immunotherapy; Immunotherapy in combination with chemotherapy; Programmed death-ligand 1 (PD-L1); Vascular endothelial growth factor(-A) (VEGF-A)

Outcome Measures

Primary Outcomes (3)

• Confirmed overall response rate

  For each treatment arm. Defined as the percentage of study participants in whom a confirmed complete response (CR) or confirmed partial response (PR) (assessed by the investigator per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]) is observed as best overall response.

  Up to 24 months

• Occurrence of treatment emergent adverse events (TEAEs) by severity

  According to (US National Cancer Institute) Common Terminology Criteria for Adverse Events version 5.0 \[CTCAE v5.0\]). By relationship and for each treatment arm.

  From the first dose of study treatment until 90 days after the last dose of study treatment (up to 32 months).

• Occurrence of dose interruptions, reductions, and discontinuations due to TEAEs

  For each treatment arm.

  Up to 24 months after first dose

Secondary Outcomes (7)

• Disease control rate

  Up to 24 months

• Duration of response

  Up to 30 months

• Progression free survival

  Up to 32 months

• Overall survival

  Up to 32 months

• Pharmacokinetic (PK) assessment: Maximum concentration (Cmax) derived from serum concentration of pumitamig

  Up to 6 months from first dose of study treatment

Study Arms (5)

Arm 1: Pumitamig (dose level 1) + chemotherapy

EXPERIMENTAL

Participants will be administered pumitamig plus chemotherapy regimen.

Drug: Pumitamig; Drug: mFOLFIRINOX

Arm 2: Pumitamig (dose level 2) + chemotherapy

EXPERIMENTAL

Participants will be administered pumitamig plus chemotherapy regimen.

Drug: Pumitamig; Drug: mFOLFIRINOX

Arm 3: Pumitamig (dose level 2) + chemotherapy

EXPERIMENTAL

Participants will be administered pumitamig plus chemotherapy regimen.

Drug: Pumitamig; Drug: Nab-paclitaxel; Drug: Gemcitabine

Arm 4A (exploratory): Pumitamig (dose level 2) + treatment of physician's choice chemotherapy

EXPERIMENTAL

Participants will be administered pumitamig plus chemotherapy regimen.

Drug: Pumitamig; Drug: Nab-paclitaxel; Drug: Gemcitabine

Arm 4B (exploratory): Pumitamig (dose level 2) + treatment of physician's choice chemotherapy

EXPERIMENTAL

Participants will be administered pumitamig plus chemotherapy regimen

Drug: Pumitamig; Drug: mFOLFIRINOX

Interventions

Pumitamig DRUG

Intravenous (IV) infusion

Also known as: BNT327, PM8002, BMS-986545

Arm 1: Pumitamig (dose level 1) + chemotherapy; Arm 2: Pumitamig (dose level 2) + chemotherapy; Arm 3: Pumitamig (dose level 2) + chemotherapy; Arm 4A (exploratory): Pumitamig (dose level 2) + treatment of physician's choice chemotherapy; Arm 4B (exploratory): Pumitamig (dose level 2) + treatment of physician's choice chemotherapy

Nab-paclitaxel DRUG

IV infusion

Arm 3: Pumitamig (dose level 2) + chemotherapy; Arm 4A (exploratory): Pumitamig (dose level 2) + treatment of physician's choice chemotherapy

Gemcitabine DRUG

IV infusion

Arm 3: Pumitamig (dose level 2) + chemotherapy; Arm 4A (exploratory): Pumitamig (dose level 2) + treatment of physician's choice chemotherapy

mFOLFIRINOX DRUG

IV infusion

Arm 1: Pumitamig (dose level 1) + chemotherapy; Arm 2: Pumitamig (dose level 2) + chemotherapy; Arm 4B (exploratory): Pumitamig (dose level 2) + treatment of physician's choice chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 not feasible to meet the required tumor tissue criteria, approval by the sponsor's medical monitor is needed for enrollment.
• 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.

You may not qualify if:

• Have received any of the following therapies or drugs before study enrollment:
• Have received prior systemic anticancer therapy for unresectable metastasis disease.
• 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.
• 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.
• Broad-spectrum intravenous antibiotics therapy within 2 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.
• Have uncontrolled hypertension or poorly controlled diabetic conditions as specified in the protocol before starting study treatment.

Sponsors & Collaborators

• BioNTech SE: lead
• Bristol-Myers Squibb: collaborator
• BioNTech (Shanghai) Pharmaceuticals Co., Ltd.: collaborator

Study Sites (10)

Tsinghua Changgung Hospital

Beijing, 102218, China

RECRUITING

Sichuan Cancer Hospital

Chengdu, 610041, China

RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, 510000, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, 325200, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, 330052, China

RECRUITING

The Affiliated Cancer Hospital of Guangxi Medical University

Nanning, 530200, China

RECRUITING

Huashan Hospital, Fudan University

Shanghai, 200040, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, 201318, China

RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, 430030, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, 450008, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• BioNTech Responsible Person

  BioNTech SE

  STUDY DIRECTOR

Central Study Contacts

BioNTech clinical trials patient information

CONTACT

+49 6131 9084; patients@biontech.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)