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Pancreatic CancerPhase 1/2NCT06069778

Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma

A Phase 1/2 study testing BNT321 0.5 mg/kg, BNT321 DL 2 and mFOLFIRINOX in people with Pancreatic Cancer, run by BioNTech SE at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study was designed as a Phase 1/randomized Phase 2 open-label study of modified(m) FOLFIRINOX ± BNT321 for adjuvant therapy in pancreatic ductal adenocarcinoma (PDAC) patients post R0 or R1 resection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
BNT321 0.5 mg/kg, BNT321 DL 2 and mFOLFIRINOX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
2 sitesUnited States
Study dates
27 Mar 2024to 18 Sep 2024
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has signed an informed consent form (ICF) before initiation of any study-specific procedures
  • Was >18 years or age deemed to be an adult per local authorities inclusive, at the time of giving written informed consent
  • Were willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions, and other requirements of the study (per investigator assessment, must been capable of understanding and following study-related instructions)
  • Had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Had histologically or cytologically confirmed PDAC
  • Had macroscopically complete resection (R0 or R1 resection, Royal College of Pathologists [RCP] classification) performed between ≥21 and ≤84 days prior to Cycle 1, Day 1 (C1D1). Submission of formalin-fixed paraffin-embedded tissue (FFPE) tumor tissue from resection or biopsy was required
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  • Had no radiologic (computed tomography/magnetic resonance imaging) evidence of metastatic disease, malignant ascites, or pleural effusion through an assessment obtained within 4 weeks of first study medication (i.e., C1D1)
  • Full recovery from surgery and able to receive chemotherapy
  • Had acceptable laboratory parameters
  • Was willing to allow collection of pharmacokinetic samples
  • Agreed not to enroll in another study of an IMP, starting after signing of the ICF and continuously until the last planned visit in this study
  • Participants of childbearing potential (POCBP) must not been pregnant. POCBP, male participants who were sexually active with POCBP, and female partners of male participants should have used a highly effective method of contraception continuously throughout the study and for a period of 111 days after the last dose of BNT321 and for 9 months (POCBP) and 6 months (male participants) after the last oxaliplatin dose
  • POCB who agreed not to donate eggs (ova, oocytes) starting after signing of the ICF and continuously throughout the study and for a period of 3 months after the last dose of BNT321 and for 9 months after the last oxaliplatin dose
  • Men who were willing to refrain from sperm donation, starting after signing of ICF and continuously throughout the study until 111 days after receiving the last dose of BNT321 and for 6 months after the last oxaliplatin dose

Who cannot join

  • Participants were pregnant or breastfeeding or planning pregnancy or to father children during the study or within 60 days after last IMP treatment
  • A medical, psychological, or social condition which, in the opinion of the investigator, could have compromised their wellbeing if they participated in the study, or that could have prevented, limited, or confounded the protocol specified assessments or procedures, or that could have impacted adherence to protocol-described requirements
  • Had major surgery within 3 weeks of first dose of the study treatment, where participation in the study could have compromised the participant's wellbeing in the opinion of the investigator
  • Had abnormal electrocardiograms (ECGs) that were clinically significant, such as Fridericia-corrected QT prolongation >470 msec (for women) and >450 msec (for men), (average of three ECGs at least 5 minutes apart)
  • Had a history of anaphylactic reaction to human, or humanized, antibody
  • Have had other known active cancer(s) likely to require treatment in the next 2 years
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  • Had prior radiotherapy or systemic treatment for PDAC
  • Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic antiinfective therapy that has been administered less than 2 weeks prior to the first dose of BNT321
  • Known hypersensitivity to any of the excipients of the experimental product BNT321
  • Known history of seropositivity for human immunodeficiency virus (HIV) with CD4+ T-cell counts <350 cells/μL and with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections
  • Known history/positive serology for Hepatitis B requiring active antiviral therapy (unless immune due to vaccination or resolved natural infection or unless passive immunization due to immunoglobulin therapy; participants with positive serology must have had Hepatitis B virus viral load below the limit of quantification)
  • Active Hepatitis C virus infection (participants who have had completed curative antiviral treatment with Hepatitis C virus viral load below the limit of quantification were allowed)
  • Use of any IMP or device within 21 days before administration of first dose of study treatment or ongoing participation in the active treatment phase of another interventional clinical study
  • Was subject to exclusion periods from another investigational study
  • Were vulnerable individuals as per ICH E6 definition, i.e., individuals whose willingness to participate in a clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
  • Serum CA19-9 >180 U/mL within 3 weeks of C1D1
  • Incomplete macroscopic tumor removal (R2 resection)
  • Significant cardiovascular risk (past medical history of coronary stenting or myocardial infarction within 6 months, or New York Heart Association (NYHA) Class III/IV, heart failure, or concurrent unstable angina) or risk factors for QT prolongation (sustained Grade 3 or higher hypokalemia, history of unstable arrhythmia or family history of long QT syndrome)
  • Pre-existing neuropathy
  • Homozygous UDP glucuronosyltransferase family 1 member A1 (UGT1A1)*28 mutation, if testing was required by local regulations
  • Inflammatory disease of the colon or rectum, or occlusion or sub-occlusion of the intestine or severe post-operative uncontrolled diarrhea
  • Complete dihydropyrimidine dehydrogenase deficiency, if testing was required by local regulations
  • Received a live vaccine within 3 weeks prior to the first dose of study treatment
  • Participants with a contraindication to receiving mFOLFIRINOX
  • Participants with active or latent tuberculosis or history of Mycobacterium tuberculosis infection currently or within the last 2 years
  • Individuals committed to an institution by virtue of an order issued either by the judicial or the administrative authorities

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

Other trials in United States

About this study

Official title: A Phase I/Randomized Phase II, Open-label Multicenter Trial to Evaluate the Safety, Tolerability, and Efficacy of mFOLFIRINOX With or Without BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma

This study was designed as a Phase 1/randomized Phase 2 open-label study of modified(m) FOLFIRINOX ± BNT321 for adjuvant therapy in pancreatic ductal adenocarcinoma (PDAC) patients post R0 or R1 resection.

The Phase 1, dose escalation part of this study was planned to be a limited evaluation of two planned BNT321 dose levels (DLs) in combination with mFOLFIRINOX chemotherapy (24 weeks) followed by BNT321 monotherapy (24 weeks). Following completion of the dose escalation Phase 1 and identification of the recommended Phase 2 dose (RP2D), the study was designed as a 2-arm, randomized Phase 2 of mFOLFIRINOX ± BNT321 to evaluate the efficacy of mFOLFIRINOX + BNT321 versus mFOLFIRINOX alone as adjuvant therapy in PDAC patients post R0 or R1 resection. Treatment cycles were every 2 weeks (14 days).

Read the detailed description

The Phase 1 part of the study was planned to be a limited dose finding evaluation, whereby a minimal number of BNT321 DLs were planned to be tested for safety and tolerability in combination with mFOLFIRINOX chemotherapy. Dose escalation was planned to be conducted using a 3+3 design, with up to six additional participants treated at the Phase 1 defined combination maximum tolerated dose (MTD). Two BNT321 DLs were initially planned, 0.5 mg/kg and a second DL 2. Following evaluation of safety profile for DL 2, additional BNT321 DLs could have been evaluated following safety data review, discussion, and approval by the safety review committee (SRC), and health authority review and approval. Approximately 20 participants were planned to be enrolled into the Phase 1 part.

Following completion of the dose escalation Phase 1 and identification of the RP2D, the study was planned to proceed to a randomized Phase 2 part. For this part, an independent data monitoring committee was planned to be be established prior to the inclusion of the first participant in this phase.

The randomized Phase 2 was designed to enroll up to 300 participants to enable a robust statistical evaluation of the study's Phase 2 primary endpoint, i.e., median disease-free survival (mDFS).

Additional evaluations for Phase 2 were planned to include determination of combination regimen safety and tolerability, determination of overall survival (OS), pharmacokinetic (PK), and pharmacodynamic (PD) analyses including anti-drug antibody (ADA), complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) assessments, cytokine and circulating tumor DNA (ctDNA) assessments.

The study was terminated early by the sponsor due to strategic reprioritization and not due to safety concerns. At the time of the termination, only one dose level (i.e., 0.5 mg/kg) of BNT321 was tested.

Being tested
BNT321 0.5 mg/kg, BNT321 DL 2, mFOLFIRINOX, BNT321 RP2D
Keywords
CA19-9 Positive Malignancies, Pancreatic Cancer and other CA19-9 expressing malignancies, Pancreatic Ductal Adenocarcinoma (PDAC), Sialyl Lewis A (sLea)
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BNT321 0.5 mg/kgDrug

    Intravenous infusion

  • BNT321 DL 2Drug

    Intravenous infusion

  • mFOLFIRINOXDrug

    Intravenous infusion

  • BNT321 RP2DDrug

    Intravenous infusion

Study groups in NCT06069778
Study groupRoleWhat they receive
Phase 1 - BNT321 0.5 mg/kg + mFOLFIRINOXExperimentalBNT321 in combination with mFOLFIRINOX chemotherapy (24 weeks) followed by BNT321 monotherapy (24 weeks)
Receives: Drug: BNT321 0.5 mg/kg; Drug: mFOLFIRINOX
Phase 1 - BNT321 DL 2 + mFOLFIRINOXExperimentalBNT321 in combination with mFOLFIRINOX chemotherapy (24 weeks) followed by BNT321 monotherapy (24 weeks)
Receives: Drug: BNT321 DL 2; Drug: mFOLFIRINOX
Phase 2 - BNT321 RP2D + mFOLFIRINOXExperimentalBNT321 in combination with mFOLFIRINOX chemotherapy (24 weeks) followed by BNT321 monotherapy (24 weeks)
Receives: Drug: mFOLFIRINOX; Drug: BNT321 RP2D
Phase 2 - mFOLFIRINOXActive comparatormFOLFIRINOX chemotherapy (24 weeks) as monotherapy
Receives: Drug: mFOLFIRINOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1 - The Number and Percentage of Participants With at Least One Dose of Investigational Medicinal Product (IMP) Reporting Treatment Emergent Adverse Events (TEAEs)

    TEAEs graded per Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0), including Grade ≥3, serious, fatal TEAE by relationship.

    Measured: from the start of study drug treatment until the end of study (i.e., 164 days)

  2. Phase 1 - The Number and Percentage of Participants With at Least One Dose of IMP Reporting Occurrence of Dose Limiting Toxicities (DLTs)

    For all Phase I cohorts the DLT assessment period was planned to encompass the treatment cycles of the first two consecutive BNT321 doses, i.e., 28 days within treatment Cycles 2 and 3.

    To be considered a DLT, an AE must have met the following three criteria:

    • Occurred during the DLT assessment period of BNT321.
    • Was considered BNT321-related (i.e., definitely related or possibly related).
    • Occurred in the presence of adequate supportive care (e.g., Grade 3 vomiting despite use of an appropriate anti-emetic regimen).

    In addition, to be considered a DLT, an AE must have met at least one of the additional criteria using CTCAE v5.0 as specified in the protocol.

    Measured: up to 28 days after first dose of BNT321

  3. Phase 2 - Disease-free Survival (DFS)

    DFS was defined as the time from randomization to occurrence of any of the following events, whichever occurs first:

    • Locoregional recurrence or distant metastases as determined by an independent central radiology assessment.
    • Occurrence of second primary (same or other) cancer as determined by an independent central radiology assessment.
    • Death from any cause.

    Measured: up to 60 months

Secondary outcomes (14)

  1. Phase 1 and 2 - OS

    OS was defined as the time from first dose of study treatment to death from any cause.

    Measured: up to 60 months

  2. Phase 1 and 2 - Relapsed Free Survival (RFS)

    RFS is defined as the time from randomization to occurrence of any of the following events, whichever occurs first:

    • Locoregional recurrence or distant metastasis as determined by the investigator.
    • Death from any cause.

    Measured: up to 60 months

  3. Phase 1 and 2 - PK Assessments: Mean Area Under the Curve (AUC) Values Derived From Serum Concentration of IMP

    Mean AUC from participants who are dosed with at least one dose of IMP and who have evaluable PK data in Cycles 2 and 3 followed by sparse sampling through end of study (EOT).

    Measured: up to 48 weeks

  4. Phase 1 and 2 - PK Assessments: Mean Observed Maximum Concentration (Cmax) Derived From Serum Concentration of IMP

    Mean Cmax from participants who are dosed with at least one dose of IMP and who have evaluable PK data in Cycles 2 and 3 followed by sparse sampling through EOT.

    Measured: up to 48 weeks

  5. Phase 1 and 2 - PK Assessments: Median Time to Reach Cmax (Tmax) Derived From Serum Concentration of IMP

    Median tmax from participants who are dosed with at least one dose of IMP and who have evaluable PK data in Cycles 2 and 3 followed by sparse sampling through EOT.

    Measured: up to 48 weeks

  6. Phase 1 and 2 - Percentage of Participants With Detectable Anti-drug Antibody (ADA)

    Percentage of participants who are dosed with at least one dose of IMP and with detectable ADA formation in Cycles 1 and 3, followed by sparse sampling through EOT

    Measured: up to 48 weeks

  7. Phase 1 and 2 - Percentage of Participants With Detectable and Durable ADCC and/or CDC Activity

    Percentage of participants who are dosed with at least one dose of IMP with detectable and durable (measurable throughout time on study) ADCC and/or CDC activity in Cycles 2 and 4, followed by sparse sampling through EOT

    Measured: up to 48 weeks

  8. Phase 1 and 2 - Change From Baseline for Participant-reported Health-related Quality of Life (HRQoL) Using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30)

    Change from baseline at end of Cycle 12 for participant-reported HRQoL using EORTC QLQ-C30

    Measured: up to 60 months

  9. Phase 1 and 2 - Change From Baseline for Participant-reported HRQoL Using EORTC Quality of Life Questionnaire for Pancreatic Cancer (QLQ-Pan26) Questionnaires

    Change from baseline at end of Cycle 12 for participant-reported HRQoL using EORTC QLQ-Pan26 questionnaires

    Measured: up to 60 months

  10. Phase 1 and 2 - Change From Baseline in Combined Item Scores From EORTC QLQ-C30

    Change from baseline at end of Cycle 12 in combined item scores from EORTC QLQ-C30

    Measured: up to 60 months

  11. Phase 1 and 2 - Change From Baseline in Combined Item Scores From EORTC QLQ-Pan26

    Change from baseline at end of Cycle 12 in combined item scores from EORTC QLQ-Pan26.

    Measured: up to 60 months

  12. Phase 2 - Occurrence of TEAEs Including Grade ≥3, Serious, Fatal TEAE by Relationship

    Measured: up to 12 months

  13. Phase 2 - Occurrence of Dose Reduction and Discontinuation of IMP Due to TEAE

    Occurrence within a participant.

    Measured: up to 12 months

  14. Phase 2 - Occurrence of Abnormal Laboratory Parameters

    Occurrence within a participant.

    Measured: up to 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2023
  2. Study start27 Mar 2024
  3. Primary completion18 Sep 2024
  4. Study completion18 Sep 2024

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06069778
Sponsor's protocol ID
BNT321-02
Other IDs
2023-506014-47, 2023
Status last verified
Oct 2025
First submitted
11 Sep 2023
Last updated
31 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BNT321 0.5 mg/kg, BNT321 DL 2 and mFOLFIRINOX in people with Pancreatic Cancer, run by BioNTech SE at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1 - The Number and Percentage of Participants With at Least One Dose of Investigational Medicinal Product (IMP) Reporting Treatment Emergent Adverse Events (TEAEs) (time frame: from the start of study drug treatment until the end of study (i.e., 164 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06069778.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.

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