What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer include chemotherapy agents such as gemcitabine and nab-paclitaxel. Known side effects of these treatments include neutropenia, fatigue, neuropathy, and gastrointestinal issues like nausea and diarrhea. For treatments similar to the experimental imaging agent 89Zr-DFO-HuMab-5B1, which involves monoclonal antibodies, potential side effects may include infusion reactions, fatigue, fever, and gastrointestinal symptoms. These treatments aim to improve imaging and targeting of pancreatic tumors, potentially leading to better diagnostic and therapeutic outcomes.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including chemotherapeutic agents like gemcitabine and nab-paclitaxel, which are often used in combination regimens such as FOLFIRINOX. These treatments aim to improve survival rates and manage symptoms. Additionally, advanced imaging techniques and targeted therapies are being explored to enhance the detection and treatment of pancreatic tumors. The trial involving 89Zr-DFO-HuMab-5B1 is an example of innovative approaches to improve PET/CT imaging by binding to pancreatic tumor cells, potentially leading to better diagnosis and treatment planning.

What other types of research exist?

One promising alternative to 89Zr-DFO-HuMab-5B1 for enhancing PET/CT imaging in pancreatic cancer is the use of 18F-FP-(+)-DTBZ. This fluorinated derivative of DTBZ has shown good pancreas specificity and potential for quantitative measurement of VMAT2, which could be useful for imaging pancreatic tumors. Another potential alternative is the use of Gallium-68 labeled agents, such as 68Ga-PSMA-11, which have been explored in other cancers and may offer high sensitivity and specificity for tumor detection.

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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

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.

Select...

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.

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I do not have any ongoing serious infections requiring treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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%

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%

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

0 / 11Eligibility criteria met

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.