← Back to Search

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

Select...

My diagnosis is pancreatic cancer confirmed by tissue analysis.

Select...

My cancer shows MUC5AC expression.

Select...

My cancer can be measured by tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to day 60

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nihon Medi-Physics Co., Ltd.Lead Sponsor

3 Previous Clinical Trials

127 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a need for new participants in this experiment?

"Affirmative. Information available on clinicaltrials.gov verify that this medical experiment, which was reported on the 31st of October 2023, is currently recruiting participants. 10 patients are needed from 1 health facility for participation in the trial."

Answered by AI

Are there any known risks associated with NMK89 usage?

"As this is a Phase 1 trial, which has limited data supporting both safety and efficacy, NMK89 received a score of 1."

Answered by AI

What is the enrollment size for this examination?

"Affirmative. The clinical trial registry hosted on clinicialtrials.gov confirms that this research endeavour, which was first advertised in October of 2023, is actively recruiting applicants. At present, the study is looking for 10 people from one site."

Answered by AI

What is the purpose of this experiment?

"According to the research sponsor, Nihon Medi-Physics Co., Ltd., their primary focus is on safety and tolerability of NMK89 through laboratory testing. Additionally, this study is also evaluating secondary outcomes such as radiation dosimetry, blood pharmacokinetics (specifically abundance ratio of unmetabolized 89Zr-labeled hNd2), and urine pharmacokinetics (concentration of total antibody in urine). All assessments will occur over an 8 day period from screening to Day 8."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety, Tolerability, Pharmacokinetics, Radiation Dosimetry, and PET Imaging Properties of 89Zr-labeled hNd2 (NMK89) in Patients With Pancreatic Cancer

2023. "Safety, Tolerability, Pharmacokinetics, Radiation Dosimetry, and PET Imaging Properties of 89Zr-labeled hNd2 (NMK89) in Patients With Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06129422.

All > Paid Studies Seattle