Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
3 participants
INTERVENTIONAL
2023-02-16
2024-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Single Arm
Eligible subjects will receive up to two zirconium Zr 89 crefmirlimab berdoxam PET scans (up to 1.0 mCi ± 20% at 1.5 mg API per scan, for a total of up to 2.0 mCi ± 20% and 3.0 mg API) as an IV infusion or slow bolus injection.
PET/CT imaging is performed 24hrs ± 3hrs post administration. The two scans are performed a minimum 2 weeks apart.
Zirconium 89Zr crefmirlimab berdoxam
Zirconium-89 labelled minibody for whole body PET imaging to visualize CD8+ cell distribution.
Interventions
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Zirconium 89Zr crefmirlimab berdoxam
Zirconium-89 labelled minibody for whole body PET imaging to visualize CD8+ cell distribution.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with at least one imageable primary or metastatic lesion \> 1 cm in the lymph nodes or soft tissue excluding bone on the most recent standard of care imaging done within the last 3 months
* Cohort 1: Patients with melanoma on single or multiple agent Immune Checkpoint Blockade (ICB) therapy with stable response status following initiation of therapy. Stable disease would be observed over at least 2 consecutive standard of care CT scans (usually done 8-12 weeks apart) after initiation of therapy.
* Cohort 2: Patients with untreated renal cell carcinoma on active surveillance
* Women of child bearing potential must not be pregnant on study entry
* Participants must agree to follow contraceptive advice while on study and for 30 days after ending participation.
Exclusion Criteria
* Patients with urinary catheters or stoma bags
* Patients who have received a vaccine recently can be included to the study but can only be scanned after a washout period of 2 weeks after the vaccine. If participants have a vaccine after the first PET-CT scan, the second PET-CT scan will be delayed for at least 2 weeks after the vaccine
* Patients on steroids except those on replacement dose of steroids for adrenal or pituitary insufficiency. Patients requiring steroids as therapy for an unresolved immune therapy related adverse event will be excluded
* Participants on immunosuppressive medication e.g. cyclosporine, azathioprine, janus kinase inhibitors
* Participant enrolled into another therapeutic intervention study
* Any other contraindication that makes the patient unsuitable to take part in the study in the opinion of the investigator
* Women who are pregnant or breast feeding
* Unable to provide informed consent
18 Years
ALL
No
Sponsors
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University of Hull
OTHER
ImaginAb, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Azeem Saleem, MB BS DMRT PhD FRCR
Role: PRINCIPAL_INVESTIGATOR
Castle Hill Hospital, Hull
Locations
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Castle Hill Hospital
Hull, , United Kingdom
Countries
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Other Identifiers
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IAB-CD8-204
Identifier Type: -
Identifier Source: org_study_id