CD8 Minibody Repeatability Study

NCT05744128 | Terminated Phase 2 FDA Drug

• 1 other identifier: IAB-CD8-204
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Zr-89 crefmirlimab berdoxam is a Zirconium-89 labelled minibody developed by ImaginAb for full body PET imaging of CD8+ cell distribution (CD8 ImmunoPET). The primary objective of this study is to assess the test-retest repeatability of CD8 immunoPET imaging in oncology patients with stable disease.

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 berdoxam BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• 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.

You may not qualify if:

• Patients with uncontrolled infection or other concurrent malignancies or conditions that may confound interpretation of the scans in the opinion of the investigator
• 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

Sponsors & Collaborators

• ImaginAb, Inc.: lead
• University of Hull: collaborator

Study Sites (1)

Castle Hill Hospital

Hull, HU16 5JQ, United Kingdom

Location

MeSH Terms

Conditions

Melanoma; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Azeem Saleem, MB BS DMRT PhD FRCR

  Castle Hill Hospital, Hull

  PRINCIPAL INVESTIGATOR

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
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)