Study of a New Technique for Imaging Pancreatic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-10

Study Completion Date

2025-01-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Pancreatic Cancer Tumors That Express CA19-9

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

MVT-2163

Intervention Type DRUG

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

MVT-5873

Intervention Type DRUG

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

Interventions

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MVT-2163

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

Intervention Type DRUG

MVT-5873

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

Intervention Type DRUG

Other Intervention Names

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89Zr-DFO-HuMab-5B1

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No