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Monoclonal Antibodies

NMK89 PET Imaging for Pancreatic Cancer

Phase 1
Recruiting
Research Sponsored by Nihon Medi-Physics Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed diagnosis of pancreatic adenocarcinoma
Confirmed MUC5AC expression at pre-screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 8
Awards & highlights

Study Summary

This trial will assess the safety/tolerance, and imaging properties of an 89Zr-labeled antibody infusion, in pancreatic cancer patients positive for MUC5AC. PET/CT imaging used.

Who is the study for?
This trial is for adults with pancreatic cancer that tests positive for MUC5AC. They must be willing to follow the study rules and provide tumor samples if needed. Pregnant women, those with severe fluid buildup, active infections like hepatitis or HIV, recent cancers (except certain treated ones), ongoing drug trials participation, significant organ damage, or uncontrolled illnesses can't join.Check my eligibility
What is being tested?
The trial studies NMK89's safety and how it moves through and affects the body when given as an infusion to pancreatic cancer patients. It involves PET/CT imaging to track the drug's distribution and effects on tumors expressing MUC5AC.See study design
What are the potential side effects?
Potential side effects of NMK89 are not detailed but may include reactions related to antibody infusions such as allergic responses, infusion-related symptoms like fever or chills, and possibly issues from radiation exposure used in PET/CT scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diagnosis is pancreatic cancer confirmed by tissue analysis.
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My cancer shows MUC5AC expression.
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My cancer can be measured by tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to day 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of a single infusion of NMK89: 12-lead ECG (Electrocardiogram) 1
Safety and tolerability of a single infusion of NMK89: 12-lead ECG 2
Safety and tolerability of a single infusion of NMK89: 12-lead ECG 3
+14 more
Secondary outcome measures
Biodistribution: Fractional injected 89Zr radioactivity values (percentage of injected dose(%ID))
Biodistribution: Time-integrated activity coefficients (TIACs) (hr)
Biological half-life of the radionuclide (hr)
+10 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: NMK89Experimental Treatment1 Intervention
Patients will receive a single infusion of NMK89

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Who is running the clinical trial?

Nihon Medi-Physics Co., Ltd.Lead Sponsor
3 Previous Clinical Trials
127 Total Patients Enrolled
~0 spots leftby Jun 2024
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