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TerminatedNCT02672917Updated Jan 28, 2025

Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies

A Phase 1 interventional study of MVT-5873 and modified FOLFIRINOX (mFOLFIRINOX) in Pancreatic Cancer, sponsored by BioNTech Research & Development, Inc.. Terminated at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-28.

Sponsored by BioNTech Research & Development, Inc. · Phase 1, Interventional, and Treatment

Why this study was terminated
Sponsor decision

From the registry’s dates

  • Primary completion was Aug 2024, 2 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
118
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Phase 1 Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies.

Read the detailed description

Open label, multicenter, non-randomized, dose escalation/expansion trial of MVT-5873 as a single agent and in combination with standard of care chemotherapy or modified FOLFIRINOX (mFOLFIRINOX) in subjects with pancreatic and other CA19-9 positive malignancies. The study was designed to define a Maximum Tolerated Dose (MTD) of MVT-5873 as monotherapy (Group A), in combination with a standard of care chemotherapy (Group B), for a Q2 week schedule (Group D), an MTD of MVT-5873 for a Q4 week schedule (Group C), and an MTD for a Q2 week schedule of MVT-5873 in combination with mFOLFIRINOX (Groups E and F). Each group utilized a conventional 3+3 study design to identify the MTD and recommended phase 2 dose (RP2D).

Following the definition of the MTD in each group, the RP2D of MVT-5873 as a single agent and in combination with mFOLFIRINOX was defined. Following completion of monotherapy dose escalation, an expansion cohort of 30 additional subjects was treated at the RP2D for Group D. Subjects were subdivided into two groups of 15 subjects; those without peripheral blood expression of C19-9 and those with peripheral blood expression of CA19-9. MVT-5873 pharmacokinetics (PK) and pharmacodynamics (PD) were determined for each group.

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • CA19-9 Positive Malignancies
  • Pancreatic Cancer and other CA19-9 expressing malignancies
  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Sialyl Lewis A (sLea)
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 118 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

BioNTech Research & Development, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Signed, informed consent
  • Age 18 or more years
  • Histologically or cytologically confirmed, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies
  • Recovered from prior treatment related toxicity to at least Grade 1 with exception of Grade 2 alopecia or other Grade 2 toxicity with approval of the Medical Monitor
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or KPS of 100% to 80%
  • Adequate hematologic, hepatic, and renal function
  • Willingness to participate in collection of pharmacokinetic samples
  • Willingness to use adequate contraception throughout study and for a period of 3 months after last dose of MVT-5873 and for up to at least 9 months after the last Oxaliplatin dose.

[Group A, C, and Group D Dose Escalation]

  • Evaluable or measurable disease based on RECISTv1.1

[Group A, C, and D]

  • Progression following treatment with standard of care for the subject's specific tumor type

[Group C and D Dose Expansion and Group E Dose Escalation and Expansion]

  • Measurable disease based on RECISTv1.1

[Group C and D Dose Expansion, non-PDAC malignancies]

  • If serum CA19-9 levels (defined as \< 1 U/mL or below the level of detection for institutional test used), subject must have confirmation of CA19-9 expression in their tumor prior to study entry (based on institutional determination of CA19-9)

[Group E and F]

  • Candidates for mFOLFIRINOX based on accepted standard of care

[Group F]

  • Histologically or cytologically confirmed PDAC
  • Macroscopically complete resection (R0 or R1 resection) performed between ≥21 and ≤84 days prior to Cycle 1, Day 1 (C1D1)
  • Baseline scans without evidence of disease (e.g., CT/MRI)
  • Serum CA19-9 ≤ 180 U/mL within 21 days of C1D1
  • Full recovery from surgery and able to receive chemotherapy
  • Free of significant nausea and vomiting
  • No prior radiotherapy or chemotherapy

Exclusion criteria

Exclusion Criteria [Groups A, B, C, D, and E]

  • Brain metastases unless previously treated and well controlled for at least 3 months prior to study day 1
  • Other known active cancer(s) likely to require treatment in the next two (2) years
  • Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
  • Fewer than 28 days (or 5 half-lives for systemic agents, whichever is shorter) from prior anticancer therapy including chemotherapy, hormonal, investigational, and/or biological therapies and irradiation (except for ongoing hormonal therapy for prostate cancer)
  • Major surgery within 28 days of Study Day 1
  • History of anaphylactic reaction to human, or humanized, antibody
  • Pregnant or currently breast-feeding
  • Known HIV, Hepatitis B or C-positive
  • Psychiatric illness/social situations that would interfere with compliance with study requirements
  • Significant cardiovascular risk (e.g., coronary stenting within 4 weeks, myocardial infarction within 6 months)

[Group F]

  • Incomplete macroscopic tumor removal (R2 resection)
  • Other known active cancer(s) likely to require treatment in the next 2 years
  • Active, uncontrolled bacterial, viral, or fungal infection (s) requiring systemic therapy
  • History of anaphylactic reaction to human, or humanized, antibody
  • Pregnant or currently breast-feeding
  • Known HIV, Hepatitis B or C-positive
  • Psychiatric illness/social situations that would interfere with compliance with study requirements
  • Significant cardiovascular risk (e.g., coronary stenting within 4 weeks, myocardial infarction within 6 months)
  • Pre-existing neuropathy
  • Known homozygous for UGT1A1*28 mutation
  • Inflammatory disease of the colon or rectum, or occlusion or sub-occlusion of the intestine or severe postoperative uncontrolled diarrhea
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
118 participants (actual)

Study arms

  • Experimental
    Group A

    MVT-5873 monotherapy dose escalation, initial to MTD

    Drug: MVT-5873

  • Experimental
    Group B

    MVT-5873 is administered in Group B every 1 week in combination with gemcitabine and nab-paclitaxel

    Drug: MVT-5873 · Drug: gemcitabine + nab-paclitaxel

  • Experimental
    Group C

    MVT-5873 is administered in Group C every 4 weeks by intravenous infusion following a lead in dose. Each cycle is 28 days. During dose escalation, doses of MVT-5873 will be increased to define the MTD. Up to 30 patients will be treated at the RP2D.

    Drug: MVT-5873

  • Experimental
    Group D

    MVT-5873 is administered in Group D every 2 weeks by intravenous infusion following a lead in dose. During dose escalation, doses of MVT-5873 will be increased to defined the MTD. Up to 30 patients will be treated at the RP2D.

    Drug: MVT-5873

  • Experimental
    Group E - metastatic

    MVT-5873 is administered in combination with mFOLFIRINOX every 2 weeks. Both MVT-5873 and mFOLFIRINOX will be administered by intravenous infusion. During dose escalation, doses of MVT-5873, will be increased to define the MTD in combination with mFOLFIRINOX. mFOLFIRINOX will be administered according to institutional standards in compliance with the package insert for each drug. Up to 30 patients will be treated at the RP2D.

    Drug: MVT-5873 · Drug: modified FOLFIRINOX (mFOLFIRINOX)

  • Experimental
    Group F - adjuvant

    MVT-5873 is administered in combination with mFOLFIRINOX every 2 weeks. Both MVT-5873 and mFOLFIRINOX will be administered by intravenous infusion. During dose escalation, doses of MVT-5873, will be increased to define the MTD in combination with mFOLFIRINOX. mFOLFIRINOX will be administered according to institutional standards in compliance with the package insert for each drug. Up to 30 patients will be treated at the RP2D.

    Drug: MVT-5873 · Drug: modified FOLFIRINOX (mFOLFIRINOX)

Interventions

  • DrugMVT-5873

    intravenous infusion (IV)

    Also known as: HuMab-5B1

  • Drugmodified FOLFIRINOX (mFOLFIRINOX)

    IV

  • Druggemcitabine + nab-paclitaxel

    IV

06

What researchers measure

Primary outcomes

  1. Group D - Determine the safety (treatment related adverse events as assessed by Common Toxicity Criteria for Adverse Events [CTCAE] V5.0) of MVT-5873 on a Q2 week schedule

    Time frame: Through study completion. Estimated at one year

  2. Group D - Determine the MTD and/or RP2D of MVT-5873 on a Q2 week schedule

    Time frame: Through study completion. Estimated at one year

  3. Group E - Determine the safety (treatment related adverse events as assessed by CTCAE V5.0) of MVT-5873 in combination with the modified FOLFIRINOX regimen (mFOLFIRINOX) in the metastatic disease setting

    Time frame: Through study completion. Estimated at one year

  4. Group E - Determine the MTD and/or the RP2D of MVT-5873 in combination with the modified FOLFIRINOX regimen (mFOLFIRINOX) in the metastatic disease setting

    Time frame: Through study completion. Estimated at one year

  5. Group F - Determine the safety (treatment related adverse events as assessed by CTCAE V5.0) of MVT-5873 in combination with the modified FOLFIRINOX regimen (mFOLFIRINOX) in the PDAC adjuvant setting

    Time frame: Through study completion. Estimated at one year

  6. Group F - Determine the MTD and/or the RP2D of MVT-5873 administered in combination with the modified FOLFIRINOX regimen (mFOLFIRINOX) in the PDAC adjuvant setting

    Time frame: Through study completion. Estimated at one year

Secondary outcomes

  1. Group D - Evaluate the hepatic safety profile (treatment related adverse events as assessed by CTCAE V5.0) of MVT-5873 in participants without elevated circulating CA19-9 expression

    Time frame: Through study completion. Estimated at one year

  2. All groups - Evaluate pharmacokinetics (PK): Area Under the Curve (AUC) for MVT-5873

    Determined using non-compartmental model.

    Time frame: Through study completion. Estimated at one year

  3. All groups - Evaluate PK: Maximum concentration (Cmax) for MVT-5873

    Determined using non-compartmental model.

    Time frame: Through study completion. Estimated at one year

  4. All groups - Evaluate PK: Plasma half-life (T1/2) for MVT-5873

    Determined using non-compartmental model.

    Time frame: Through study completion. Estimated at one year

  5. Groups A, B, C, D, E - Evaluate tumor response rate

    Time frame: Through study completion. Estimated at one year

  6. Groups A, B, C, D, E - Evaluate duration of response

    Time frame: Through study completion. Estimated at one year

  7. Groups A, B, C, D, E - Evaluate time to response

    Time frame: Through study completion. Estimated at one year

  8. Groups A, B, C, D, E - Evaluate progression free survival

    Time frame: Through study completion. Estimated at one year

  9. All groups - Evaluate overall survival

    Time frame: Through study completion. Estimated at one year

  10. Group F - Evaluate disease free survival

    Time frame: Through study completion. Estimated at one year

  11. Group F - Evaluate time to recurrence

    Time frame: Through study completion. Estimated at one year

07

Study locations

5 sites
  • HonorHealth Research Institute
    Scottsdale, Arizona 85258, United States
  • The Angeles Clinic & Research Institute
    Los Angeles, California 90025, United States
  • Florida Cancer Specialist and Research Institute
    Sarasota, Florida 34233, United States
  • MSKCC
    New York, New York 10065, United States
  • Sarah Cannon Research Institute
    Nashville, Tennessee 37203, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02672917
Lead sponsor
BioNTech Research & Development, Inc.
Responsible party
Sponsor
First posted
Feb 3, 2016
Start date
Jan 2016
Primary completion
Aug 7, 2024
Completion
Jan 14, 2025
Last update
Jan 28, 2025

Study contacts

BioNTech Responsible Person
study director · BioNTech SE

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
View the source record on ClinicalTrials.gov ↗

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