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Pancreatic CancerPhase 1NCT02672917

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

A Phase 1 study testing MVT-5873, modified FOLFIRINOX (mFOLFIRINOX) and gemcitabine + nab-paclitaxel in people with Pancreatic Cancer, run by BioNTech Research & Development, Inc. at 5 sites in United States.

Terminated

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

Official record
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Trial summary

Phase 1 Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies. 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?
MVT-5873, modified FOLFIRINOX (mFOLFIRINOX) and gemcitabine + nab-paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
5 sitesUnited States
Study dates
Jan 2016to 14 Jan 2025
Phase
Phase 1
Are there results?
None posted in the registry

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

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • The Angeles Clinic & Research Institute

    Los Angeles, California, 90025

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • MSKCC

    New York, New York, 10065

  • Florida Cancer Specialist and Research Institute

    Sarasota, Florida, 34233

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: Phase 1 Safety and Tolerability Study of Human Monoclonal Antibody 5B1 (MVT-5873) With Expansion in Subjects With Pancreatic Cancer or Other CA19-9 Positive Malignancies

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.

Being tested
MVT-5873, modified FOLFIRINOX (mFOLFIRINOX), gemcitabine + nab-paclitaxel
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.

  • MVT-5873Drug

    Also called HuMab-5B1

    intravenous infusion (IV)

  • modified FOLFIRINOX (mFOLFIRINOX)Drug

    IV

  • gemcitabine + nab-paclitaxelDrug

    IV

Study groups in NCT02672917
Study groupRoleWhat they receive
Group AExperimentalMVT-5873 monotherapy dose escalation, initial to MTD
Receives: Drug: MVT-5873
Group BExperimentalMVT-5873 is administered in Group B every 1 week in combination with gemcitabine and nab-paclitaxel
Receives: Drug: MVT-5873; Drug: gemcitabine + nab-paclitaxel
Group CExperimentalMVT-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.
Receives: Drug: MVT-5873
Group DExperimentalMVT-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.
Receives: Drug: MVT-5873
Group E - metastaticExperimentalMVT-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.
Receives: Drug: MVT-5873; Drug: modified FOLFIRINOX (mFOLFIRINOX)
Group F - adjuvantExperimentalMVT-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.
Receives: Drug: MVT-5873; Drug: modified FOLFIRINOX (mFOLFIRINOX)

What is being measured

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

  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

    Measured: Through study completion. Estimated at one year

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Through study completion. Estimated at one year

Secondary outcomes (11)

  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

    Measured: 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.

    Measured: Through study completion. Estimated at one year

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

    Determined using non-compartmental model.

    Measured: 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.

    Measured: Through study completion. Estimated at one year

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

    Measured: Through study completion. Estimated at one year

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

    Measured: Through study completion. Estimated at one year

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

    Measured: Through study completion. Estimated at one year

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

    Measured: Through study completion. Estimated at one year

  9. All groups - Evaluate overall survival

    Measured: Through study completion. Estimated at one year

  10. Group F - Evaluate disease free survival

    Measured: Through study completion. Estimated at one year

  11. Group F - Evaluate time to recurrence

    Measured: Through study completion. Estimated at one year

Timeline

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

  1. First posted3 Feb 2016 (estimated)
  2. Study startJan 2016
  3. Primary completion7 Aug 2024
  4. Study completion14 Jan 2025

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02672917
Sponsor's protocol ID
MV-0715-CP-001.01
Status last verified
Jan 2025
First submitted
25 Jan 2016
Last updated
28 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MVT-5873, modified FOLFIRINOX (mFOLFIRINOX) and gemcitabine + nab-paclitaxel in people with Pancreatic Cancer, run by BioNTech Research & Development, Inc. at 5 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 26 inclusion and 22 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 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 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.

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

Are results available for this study?

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

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?

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). The study lists 6 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 NCT02672917.

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 28 Jan 2025.

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