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Study of a New Technique for Imaging Pancreatic Cancer

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04883775
Collaborator
BioNTech SE (Industry)
15
Enrollment
7
Locations
1
Arm
23.7
Anticipated Duration (Months)
2.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Diagnostic
Official Title:
89Zr-DFO-HuMab-5B1 (MVT-2163) Imaging in Pancreatic Cancer or Other CA19-9 Positive Malignancies
Actual Study Start Date :
May 10, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 89Zr-DFO-HuMab-5B1 (MVT-2163) Imaging

All 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.

Drug: MVT-2163
MVT-2163 is administered intravenously as a PET imaging agent.
Other Names:
  • 89Zr-DFO-HuMab-5B1

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

    Outcome Measures

    Primary Outcome Measures

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

      assessed by CTCAE v4.0

    2. Biodistribution of MVT-2163 [1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    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:

    • Biopsy-proven or high suspicion on imaging for pancreatic ductal adenocarcinoma (PDAC) (Stage T2 and T3) and

    • Patient scheduled to undergo surgery as standard of care for their pancreatic adenocarcinoma OR

    • Patients with Intraductal papillary mucinous neoplasm (IPMN) scheduled to undergo surgery as standard of care.

    The suspicion for pancreatic carcinoma and decision for surgery 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
    Exclusion Criteria:

    • 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memoral Sloan Kettering Basking Ridge (Consent only) Basking Ridge New Jersey United States 07920
    2 Memoral Sloan Kettering Monmouth (Consent only) Middletown New Jersey United States 07748
    3 Memorial Sloan Kettering Bergen (Consent only ) Montvale New Jersey United States 07645
    4 Memorial Sloan Kettering Cancer Center @ Commack (Consent Only) Commack New York United States 11725
    5 Memoral Sloan Kettering Westchester (Consent only) Harrison New York United States 10604
    6 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    7 Memorial Sloan Kettering Nassau (Consent Only) Uniondale New York United States 11553

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center
    • BioNTech SE

    Investigators

    • Principal Investigator: Neeta Pandit-Taskar, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04883775
    Other Study ID Numbers:
    • 20-342
    First Posted:
    May 12, 2021
    Last Update Posted:
    May 4, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Memorial Sloan Kettering Cancer Center
    89Zr-DFO-HuMab-5B1 (MVT-2163)
    Imaging
    MVT-5873
    20-342
    Additional relevant MeSH terms:
    Pancreatic Neoplasms

    Study Results

    No Results Posted as of May 4, 2022