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New Imaging Technique for Pancreatic Cancer

Phase 1
Waitlist Available
Led By Neeta Pandit-Taskar, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients scheduled referred to surgery or biopsy as standard of care for their pancreatic adenocarcinoma
Histologically confirmed, locally-advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC) or other malignancies known to express CA19-9 positive malignancies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing a new imaging agent to see if it can better detect pancreatic cancer.

Who is the study for?
This trial is for adults with advanced pancreatic cancer or tumors that show a marker called CA19-9. They must be scheduled for surgery, have certain blood and organ function levels within set limits, and not be pregnant or breastfeeding. People with major recent surgeries, uncontrolled infections, HIV, or severe psychiatric issues cannot join.Check my eligibility
What is being tested?
The study tests an experimental imaging agent named 89Zr-DFO-HuMab-5B1 to see how well it attaches to pancreatic tumors during PET/CT scans. The goal is to improve the quality of tumor images in patients who are about to undergo surgery.See study design
What are the potential side effects?
Potential side effects may include allergic reactions due to the humanized antibody nature of MVT-2163 and MVT-5873. Specific side effects aren't listed but could relate to typical imaging contrast agents like mild pain, swelling at injection site, or rare anaphylactic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for surgery or biopsy for my pancreatic cancer as part of my standard treatment.
Select...
My cancer is advanced pancreatic or CA19-9 positive.
Select...
I am recommended for surgery or biopsy for my IPMN condition.
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I can care for myself and am up and about more than 50% of my waking hours.
Select...
My pancreatic cancer is confirmed or highly suspected to be at stage T2 or T3.
Select...
My pancreatic cancer is confirmed or highly suspected and is at an intermediate stage.
Select...
I am scheduled for surgery for my pancreatic cancer or IPMN.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biodistribution of MVT-2163
Number of subjects with treatment-related adverse events as assessed

Side effects data

From 2022 Phase 2 trial • 10 Patients • NCT03801915
100%
Pleural effusion
100%
Hepatobiliary disorders - Other, Bile duct perforation
100%
Aspartate aminotransferase increased
100%
Blood bilirubin increased
100%
Creatinine increased
100%
Somnolence
100%
Urine output decreased
100%
Vomiting
100%
Abdominal infection
100%
Abdominal pain
100%
Confusion
100%
Lymphocyte count decreased
100%
Hyperkalemia
100%
Hypotension
100%
Alkaline phosphatase increased
100%
Alanine aminotransferase increased
100%
Anemia
100%
Dyspnea
100%
Hypoalbuminemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2 - Pre-operative Recommended Dose (RD) of MVT-5873 (HuMab-5B1)
Cohort 1 - Pre-operative Escalation Doses of MVT-5873 (HuMab-5B1)

Trial Design

1Treatment groups
Experimental Treatment
Group I: 89Zr-DFO-HuMab-5B1 (MVT-2163) ImagingExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MVT-5873
2019
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,940 Previous Clinical Trials
588,907 Total Patients Enrolled
BioNTech SEIndustry Sponsor
66 Previous Clinical Trials
108,229 Total Patients Enrolled
Neeta Pandit-Taskar, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
9 Previous Clinical Trials
311 Total Patients Enrolled

Media Library

MVT-5873 Clinical Trial Eligibility Overview. Trial Name: NCT04883775 — Phase 1
Pancreatic Cancer Research Study Groups: 89Zr-DFO-HuMab-5B1 (MVT-2163) Imaging
Pancreatic Cancer Clinical Trial 2023: MVT-5873 Highlights & Side Effects. Trial Name: NCT04883775 — Phase 1
MVT-5873 2023 Treatment Timeline for Medical Study. Trial Name: NCT04883775 — Phase 1
~1 spots leftby May 2025
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