Trials Sponsors Conditions Drugs Pricing

Conditions

Melanoma Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

SUVs in tumor
Absolute and relative difference in tumor SUVs
2-4 weeks
SUVs in reference tissues
Absolute and relative difference in reference tissue SUVs
2-4 weeks
ratio of tumor SUVs to reference tissue SUVs
Absolute and relative difference in SUV ratios
2-4 weeks

Secondary Outcomes (1)

Safety of repeat doses of Zr-89 crefmirlimab berdoxam
Through study completion, an average of 8 weeks

Study Arms (1)

Single Arm

OTHER

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.

Biological: Zirconium 89Zr crefmirlimab berdoxam

Interventions

Zirconium 89Zr crefmirlimab berdoxamBiological

Zirconium-89 labelled minibody for whole body PET imaging to visualize CD8+ cell distribution.

Also known as: Zr-89 Df-crefmirlimab, Zr-89 Df-IAB22M2C

Single Arm

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Aged 18 years and above
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

Sponsors & Collaborators

University of Hull
Othercollaborator
ImaginAb, Inc.
Industrylead

Study Sites (1)

Castle Hill Hospital

Hull, HU16 5JQ, United Kingdom

MeSH Terms

Conditions

MelanomaCarcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinoma

Study Officials

Azeem Saleem, MB BS DMRT PhD FRCR
Castle Hill Hospital, Hull
PRINCIPAL INVESTIGATOR

Enrollment

3 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 19, 2023

First Posted

February 24, 2023

Study Start

February 16, 2023

Actual (reported)

Study Stopped

CD8 Minibody Repeatability Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (1)

Study Arms (1)

Single Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (1)

Study Arms (1)

Single Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations