Study of a New Technique for Imaging Pancreatic Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatic Cancer; Tumors That Express CA19-9
• Intervention / Treatment: Drug: MVT-2163; Drug: MVT-5873

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Neeta Pandit-Taskar, MD; Phone Number: 212-639-3046; Email: pandit-n@mskcc.org
• Study Contact Backup: Name: Jason Lewis, PhD; Phone Number: 646-888-3080

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Basking Ridge (Consent only)
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth (Consent only)
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Bergen (Consent only )
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester (Consent only)
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • Uniondale, New York, United States, 11553
      • Memorial Sloan Kettering Nassau (Consent Only)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• 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.

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

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with treatment-related adverse events as assessed	assessed by CTCAE v4.0	1 year
Biodistribution of MVT-2163	will be determined by measuring radiation exposure for key organs and tissues	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: BioNTech SE
• Investigators: Principal Investigator: Neeta Pandit-Taskar, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Estimated): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Imaging; 89Zr-DFO-HuMab-5B1 (MVT-2163); MVT-5873; 20-342
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 20-342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No