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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
Must not have
Other on-going cancer therapy or investigational agents (except MVT-5873)
Major surgery other than diagnostic surgery within 4 weeks of Study Day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new imaging substance called 89Zr-DFO-HuMab-5B1. It aims to help doctors see pancreatic tumors more clearly during scans. The study focuses on people with pancreatic cancer to improve how well these tumors can be seen.

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.
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.
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.
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My cancer is advanced pancreatic or CA19-9 positive.
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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.
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I am scheduled for surgery for my pancreatic cancer or IPMN.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not on any cancer treatment except MVT-5873.
Select...
I have not had major surgery in the last 4 weeks.
Select...
I have been diagnosed with HIV.
Select...
I do not have any ongoing serious infections requiring treatment.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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%
Hepatobiliary disorders - Other, Bile duct perforation
100%
Pleural effusion
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for pancreatic cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy, such as gemcitabine, works by interfering with the DNA replication of cancer cells, thereby inhibiting their growth and proliferation. Targeted therapies, like erlotinib, block specific molecules involved in tumor growth and progression. Immunotherapy, including checkpoint inhibitors, enhances the body's immune response against cancer cells. The trial involving 89Zr-DFO-HuMab-5B1 focuses on an experimental imaging agent that binds to pancreatic tumor cells, improving PET/CT imaging accuracy. This is crucial for pancreatic cancer patients as it can lead to better tumor localization, more precise treatment planning, and potentially improved outcomes.
[Metastasis of pancreatic tumors].Current and future strategies for combined-modality therapy in pancreatic cancer.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,976 Previous Clinical Trials
599,496 Total Patients Enrolled
BioNTech SEIndustry Sponsor
77 Previous Clinical Trials
115,861 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
~0 spots leftby May 2025