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Pancreatic CancerPhase 1NCT04883775

Study of a New Technique for Imaging Pancreatic Cancer

A Phase 1 study testing MVT-2163 and MVT-5873 in people with Pancreatic Cancer and Tumors That Express CA19-9, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to see how well the experimental imaging agent 89Zr-DFO-HuMab-5B1 attaches to pancreatic tumors, and to find out whether PET/CT scans done with this imaging agent produce better images of cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer, Tumors That Express CA19-9
What is being tested?
MVT-2163 and MVT-5873
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
7 sitesUnited States
Study dates
10 May 2021to 27 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

  • PART I : ESCALATION, EXPANSION, RE-ENTRY COHORTS:
  • Histologically confirmed, locally-advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC) or other malignancies known to express CA19-9 positive malignancies
  • PART II: PRE-SURGERY COHORT ONLY:
  • Patients with biopsy-proven or high suspicion on imaging for pancreatic ductal adenocarcinoma (PDAC) (Stage T2 and T3)
  • Patients scheduled referred to surgery or biopsy as standard of care for their pancreatic adenocarcinoma OR
  • Patients with Intraductal papillary mucinous neoplasm (IPMN) referred to surgery or biopsy as standard of care.
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  • The suspicion for pancreatic carcinoma and decision for surgery or biopsy will be based on review of imaging and clinical findings in the disease management team discussion including surgeon and radiologist.
  • PART I and II:
  • Signed, informed consent
  • Age 18 or more years
  • At least one lesion by CT or MRI ≥ 2 cm, unless determine otherwise for pre-surgery cohort subjects
  • CA19-9 serum level:
  • For Part I: >ULN or CA19-9 positive biopsy (optional);
  • For Part II ( presurgical cohort): CA19-9 serum level (normal or high levels are allowed) or CA19-9 positive biopsy (optional)
  • ECOG performance status of 0 to 2
  • Adequate laboratory parameters including:
  • Absolute neutrophil count (ANC) ≥1.5 x 10^9/L
  • Hemoglobin ≥ 9.0 g/dL (in the absence of red blood cell transfusions in the prior 14 days)
  • Platelet count >75,000/ mm^3
  • AST/SGOT, ALT/SGPT ≤2.5 x ULN, unless liver metastases are clearly present, then ≤5.0 x ULN
  • Total bilirubin ≤1.5x the upper limit of normal unless considered due to Gilbert's syndrome in which case, ≤3x the upper limit of normal
  • Creatinine (serum or plasma) ≤ 1.5 x ULN or eGFR>50 mL/min
  • PART I: ESCALATION, EXPANSION, RE-ENTRY COHORTS:
  • Willingness to participate in collection of pharmacokinetic samples

Who cannot join

  • Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
  • Major surgery other than diagnostic surgery within 4 weeks of Study Day 1
  • History of anaphylactic reaction to human, or humanized, antibody
  • Other on-going cancer therapy or investigational agents (except MVT-5873)
  • Known history of HIV
  • Pregnant or currently breast-feeding
  • Psychiatric illness/social situations that would interfere with compliance with study requirements
  • Prior entry onto this protocol 3 or more times (e.g., subjects may enter this protocol and be imaged up to 3 times)

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Memorial Sloan Kettering Basking Ridge (Consent only)

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (Consent only)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth (Consent only)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (Consent only )

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (Consent Only)

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: 89Zr-DFO-HuMab-5B1 (MVT-2163) Imaging in Pancreatic Cancer or Other CA19-9 Positive Malignancies

The purpose of this study is to see how well the experimental imaging agent 89Zr-DFO-HuMab-5B1 attaches to pancreatic tumors, and to find out whether PET/CT scans done with this imaging agent produce better images of cancer.

Being tested
MVT-2163, MVT-5873
Keywords
89Zr-DFO-HuMab-5B1 (MVT-2163), Imaging, MVT-5873, 20-342
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-2163Drug

    Also called 89Zr-DFO-HuMab-5B1

    MVT-2163 is administered intravenously as a PET imaging agent.

  • MVT-5873Drug

    MVT-5873 will be administered intravenously over at least 60 minutes.

Study groups in NCT04883775
Study groupRoleWhat they receive
89Zr-DFO-HuMab-5B1 (MVT-2163) ImagingExperimentalAll subjects will receive a single, fixed, intravenous dose of MVT-2163, consisting of 3 mg (nominal mass - actual mass administered will likely vary between 2.0 and 2.5 mg) of MVT-2163 radiolabeled from 5 mCi to no less than 1.0 mCi (adjusted as of 16-Mar 2017) of 89Zr.Cohort 1 subjects will receive MVT-2163, with no MVT-5873 pre-dosing. Subjects in subsequent cohorts 2 and 3 will receive a dose of MVT-5873 15 minutes, ~ 2 hours, and ~4 hours prior to administration of MVT-2163. Future cohorts 4 and 5 may evaluate alternate time frames. Other cohorts may evaluate administration of MVT-5873 one week prior (D-7) to the day of MVT-2163 administration and a second administration of MVT-5873 the day of (D0) MVT-2163 administration. The re-entry (RE) and pre-surgery (PS) cohorts will administer MVT-2163 3 ± 1 hour after administration of MVT-5873.
Receives: Drug: MVT-2163; Drug: MVT-5873

What is being measured

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

  1. Number of subjects with treatment-related adverse events as assessed

    assessed by CTCAE v4.0

    Measured: 1 year

  2. Biodistribution of MVT-2163

    will be determined by measuring radiation exposure for key organs and tissues

    Measured: 1 year

Timeline

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

  1. First posted12 May 2021
  2. Study start10 May 2021
  3. Primary completion27 Jan 2025
  4. Study completion27 Jan 2025

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
This is a phase I, open label, nonrandomized, dose-escalation trial of a fixed dose of MVT-2163 (89Zr-DFO-HuMab-5B1) and varying antibody masses of MVT-5873 (HuMab-5B1), designed to identify an optimal dose (total antibody mass) and optimal timing, for tumor imaging. This trial will include dose escalation, which includes up to 5 cohorts, an expansion phase, a re-entry phase, and a pre-surgery phase.
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04883775
Sponsor's protocol ID
20-342
Status last verified
Jan 2025
First submitted
10 May 2021
Last updated
30 Jan 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MVT-2163 and MVT-5873 in people with Pancreatic Cancer and Tumors That Express CA19-9, run by Memorial Sloan Kettering Cancer Center at 7 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 24 inclusion and 8 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: finished, as of the sponsor's last update on 30 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 7 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of subjects with treatment-related adverse events as assessed (time frame: 1 year). The study lists 2 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 NCT04883775.

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 30 Jan 2025.

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