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Pancreatic CarcinomaPhase 1NCT02687230

Phase 1 Imaging Study of 89Zr-DFO-HuMab-5B1 With HuMab-5B1

A Phase 1 study testing MVT-2163 and MVT-5873 in people with Pancreatic Carcinoma and Tumors That Express CA19-9, run by BioNTech Research & Development, Inc. at 1 site 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

Open label, nonrandomized, dose-escalation trial of MVT-2163 and MVT-5873 used in performing PET scans. The study is designed to determine the best time and dose of these agents that result in the best PET image of a tumor. Subjects will be seen on days 1, 2, 4, and 7 for imaging and a clinical assessment. Read more about this study

Who is it for?
Ages 18 years and older
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
15 participants
Where
1 siteUnited States
Study dates
11 Jul 2016to 5 May 2017
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
  • Histologically confirmed, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other malignancies known to express CA19-9 positive malignancies
  • At least one lesion by CT or MRI ≥ 2 cm
  • ECOG performance status of 0 to 2
  • Absolute neutrophil count ≥1.50 x 109/L
  • Hemoglobin ≥ 9.0 g/dL (in the absence of red blood cell transfusions in the prior 14 days)
Show all 13Show fewer
  • Platelet count >75,000/ mm3
  • 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
  • Serum creatinine (serum or plasma) ≤ 1.5 x ULN or GFR>50 mL/min
  • Serum albumin > 3.0g/dL
  • Willingness to participate in collection of pharmacokinetic samples
  • Willingness to use adequate contraception throughout study and for a period of 90 days last dose of study drug

Who cannot join

  • Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
  • Major surgery other than diagnostic surgery within 28 days
  • History of anaphylactic reaction to human, or humanized, antibody
  • Other on-going cancer therapy or investigational agents (except MVT-5873 )
  • Known history of HIV or Hepatitis C
  • Pregnant or currently breast-feeding
  • Psychiatric illness/social situations that would interfere with compliance with study requirements
  • Significant cardiovascular risk including, but not limited to, recent (within 28 days) coronary stenting or myocardial infarction within 6 months

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: Phase 1 Study of 89Zr-DFO-HuMab-5B1 (MVT-2163) With HuMab-5B1 (MVT-5873) in Patients With Pancreatic Cancer or Other CA19-9 Positive Malignancies

Open label, nonrandomized, dose-escalation trial of MVT-2163 and MVT-5873 used in performing PET scans. The study is designed to determine the best time and dose of these agents that result in the best PET image of a tumor. Subjects will be seen on days 1, 2, 4, and 7 for imaging and a clinical assessment. The last study visit is on day 28.

Read the detailed description

This is an open label, nonrandomized, dose-escalation trial of a fixed dose of MVT-2163 and varying antibody masses of MVT-5873. The study is designed to identify an optimal dose (total antibody mass) and optimal timing, for tumor imaging using PET scanning. This trial will include a dose escalation and an expansion phase. During the dose escalation portion of the study, a determination of the optimal time to perform PET imaging will be made. Following the identification of the "optimal" dose and timing, an 10 additional subjects will be imaged using the best dose and timing.

In each portion of the study subjects will have a screening visit and, no more than 28 days later, those who are eligible for the study will receive MVT-2163. Each cohort will have 3-6 subjects. Subjects in cohort 1 will be administered MVT-2163 alone on day 1. Subjects in cohorts 2 and 3 will receive MVT-5873 on day 1, followed approximately 10 minutes later by MVT-2163. Subjects will return for visits to the clinic on days 2, 4, and 7 for additional imaging and safety assessments. A follow-up visit will occur on day 28.

The study will also evaluate the tissue distribution and pharmacokinetics of MVT-2163 and, based on these data, the study will estimate the radiation dosimetry of MVT-2163. Safety assessments will be performed using ECGs, vital signs measurements, assessments of performance status, and clinical laboratory measurements.

Being tested
MVT-2163, MVT-5873
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

    Also called HuMab-5B1

    MVT-5873 is administered intravenously as a non-radioactive blocking agent prior to administration of MVT-2163

Study groups in NCT02687230
Study groupRoleWhat they receive
Cohort 1ExperimentalSubjects receive 3 mg of MVT-2163 without the addition of prior MVT-5873.
Receives: Drug: MVT-2163
Cohort 2ExperimentalSubjects receive 17 mg of MVT-5873 followed by 3 mg of MVT-2163.
Receives: Drug: MVT-2163; Drug: MVT-5873
Cohort 3ExperimentalSubjects receive 47 mg of MVT-5873 followed by 3 mg of MVT-2163.
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. Safety of MVT-2163 alone and in combination with MVT-5873

    Number of subjects with treatment-related adverse events as assessed by CTCAE v4.0 will be collected and compiled

    Measured: About 12 months

  2. Peak Plasma Concentration (Cmax) of MVT-2163 alone and in combination with MVT-5873

    Cmax of MVT-2163

    Measured: About 12 months

  3. Biodistribution of MVT-2163 alone and in combination with MVT-5873

    The biodistribution of MVT-2163 will be determined by measuring radiation exposure for key organs and tissues

    Measured: About 12 months

  4. Dose of MVT-5873 required for optimal tumor visualization when combined with a fixed dose of MVT-2163

    Three doses of MVT-5873 (0, 17, and 47 mg) will be combined with MVT-2163 in order to determine which dose results in the best PET imaging of tumor

    Measured: About 12 months

  5. Determine the optimal time interval between MVT-2163 dose administration and tumor PET imaging

    Images will be taken on several days over the first week to determine the optimal day for obtaining PET images

    Measured: About 12 months

  6. Area under the plasma concentration versus time curve (AUC) of MVT-2163 alone and in combination with MVT-5873

    AUC of MVT-2163

    Measured: About 12 months

  7. Half-life (T1/2) of MVT-2163 alone and in combination with MVT-5873

    Half-life (T1/2) of MVT-2163

    Measured: About 12 months

Secondary outcomes (5)

  1. The ability of MVT-2163 to detect sites of disease (localized and metastatic) in pancreatic cancer and/or other CA19-9 positive malignancies

    PET scans obtained with MVT-2163 will be compared with conventional imaging (CT/MRI) to determine if MVT-2163 based PET scans are capable of detection tumors seen with conventional methods

    Measured: About 12 months

  2. Radiation dosimetry estimates using quantitative MVT-2163 biodistribution uptake data

    Bio-distribution data will be used to estimate the radiation exposure of key organs and tissues

    Measured: About 12 months

  3. MVT-2163 PET imaging results in comparison with varying levels of CA19-9 antigen expression by IHC

    A determination will be made as to the effect of varying levels of CA19-9 antigen expression by tumor IHC on the quality of MVT-2163 PET imaging

    Measured: About 12 months

  4. MVT-2163 PET imaging results in comparison with circulating CA19-9 levels

    A determination will be made as to the effect of circulating levels of CA19-9 on the quality of MVT-2163 PET imaging

    Measured: About 12 months

  5. Presence of anti-drug antibodies (ADA) using an MVT-5873 ADA assay

    Subjects will be tested for the development of anti-drug antibodies (ADA) against MVT-5873

    Measured: About 12 months

Timeline

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

  1. First posted22 Feb 2016 (estimated)
  2. Study start11 Jul 2016
  3. Primary completion5 May 2017
  4. Study completion5 May 2017

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
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02687230
Sponsor's protocol ID
MV-0815-CP-001.01
Status last verified
Aug 2021
First submitted
9 Feb 2016
Last updated
31 Aug 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Tully KM, Tendler S, Carter LM, Sharma SK, Samuels ZV, Mandleywala K, Korsen JA, Delos Reyes AM, Piersigilli A, Travis WD, Sen T, Pillarsetty N, Poirier JT, Rudin CM, Lewis JS. Radioimmunotherapy Targeting Delta-like Ligand 3 in Small Cell Lung Cancer Exhibits Antitumor Efficacy with Low Toxicity. Clin Cancer Res. 2022 Apr 1;28(7):1391-1401. doi: 10.1158/1078-0432.CCR-21-1533.

    PubMed 35046060

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MVT-2163 and MVT-5873 in people with Pancreatic Carcinoma and Tumors That Express CA19-9, run by BioNTech Research & Development, Inc. at 1 site 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 13 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: stopped early, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Safety of MVT-2163 alone and in combination with MVT-5873 (time frame: About 12 months). The study lists 7 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 NCT02687230, which also lists 1 linked publication.

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 Aug 2021.

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