PRETZCEL: CD8 minibody repeatability study

Phase 3

Completed

• Conditions: Melanoma, renal cell carcinoma; Cancer

• Registration Number: ISRCTN71215418
• Lead Sponsor: ImaginAb (United States)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-03
• Study Completion: 2024-05-29
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

All participants:
1. Aged =18 years
2. =1 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
3. Agree to follow contraceptive advice while on study until 33 days after ending participation

Cohort 1:
1. Melanoma on single or multiple agent Immune Checkpoint Blockade (ICB) therapy with stable response status following initiation of therapy
2. Stable disease observed over =2 consecutive standard of care CT scans (usually done 8-12 weeks apart) after initiation of therapy

Cohort 2:
1. Untreated renal cell carcinoma on active surveillance

Exclusion Criteria

1. Uncontrolled infection or other concurrent malignancies or conditions that may confound interpretation of the scans in the opinion of the study doctor
2. Urinary catheters or stoma bags
3. Patients who have received a COVID vaccine can be included in the study but can only be scanned after a washout period of 2 weeks after the vaccine. If patients have a COVID vaccine after the first PET-CT scan, the second PET-CT scan will be delayed for =2 weeks after the COVID vaccine.
4. Taking 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.
5. Taking immunosuppressive medication e.g. cyclosporine, azathioprine, or janus kinase inhibitors
6. Enrolled in another therapeutic intervention study
7. Any other contraindication that makes the patient unsuitable to take part in the study in the opinion of the investigator
8. Women of child bearing potential who are pregnant or breastfeeding on study entry
9. Unable to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Differences in normal tissue, and tumor uptake, measured standardized uptake values (SUV mean, SUVmax, and SUVpeak) between the two PET-CT scans at baseline and 4-8 weeks<br>2. Differences in normal tissue, and tumor uptake normalized to a reference region measured as standardized uptake value ratio between the two PET-CT scans at baseline and 4-8 weeks

Secondary Outcome Measures

Name	Time	Method
Safety measured using the incidence of adverse events collected between the start of the trial and 33 days after the participants' last PET-CT scan