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Monoclonal Antibodies

Imaging with Zr-89 Crefmirlimab Berdoxam for Brain Cancer

Phase 1

Waitlist Available

Led By Robert M Prins

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documentation of a diagnosis of brain tumor including brain metastases, any grade of gliomas and meningiomas

Be older than 18 years old

Must not have

Male or female < 18 years of age

Not medically cleared for surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 month

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to use a new imaging technique called immuno-positron emission tomography (PET) with a substance called zirconium (Zr)-89 crefmirlimab berdo

Who is the study for?

This trial is for patients with brain tumors that can be surgically removed. It's suitable for those who need their immune cell activity checked without invasive procedures like repeat biopsies, which may not show the full picture.

What is being tested?

The study tests Zr-89 crefmirlimab berdoxam combined with immuno-PET scans to track CD8+ T-cell activity in the tumor. This could help assess how well a patient might respond to cancer immunotherapy more accurately than current methods.

What are the potential side effects?

Potential side effects are not detailed here but may include reactions related to PET imaging or the radioimmunoconjugate, such as allergic responses or discomfort at injection sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a brain tumor, including brain metastases, gliomas, or meningiomas.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I am not cleared for surgery by a doctor.

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My kidney function, measured by creatinine or GFR, is within the normal range.

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I have had my spleen removed or it doesn't work properly.

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I have no health issues that prevent me from using gadolinium contrast.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Zirconium (Zr)-89 crefmirlimab berdoxam uptake

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: Treatment (Zr-89 crefmirlimab berdoxam + ImmunoPET)Experimental Treatment7 Interventions

Patients receive Zr-89 crefmirlimab berdoxam IV over 5-10 minutes 3 days prior to scheduled surgical resection. Approximately 24 hours after receiving Zr-89 crefmirlimab berdoxam, patients undergo immuno-PET scans. Patients then undergo scheduled standard of care surgical resection of the brain tumor and brain biopsy. Additionally, patients undergo advanced physiologic and metabolic MRI and MRI prior to surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Advanced Magnetic Resonance Imaging

2021

N/A

~20

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180