MelanomaPhase 2PRETZCELNCT05744128
CD8 Minibody Repeatability Study
A Phase 2 study testing Zirconium 89Zr crefmirlimab berdoxam in people with Melanoma and Renal Cell Carcinoma, run by ImaginAb, Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Renal Cell Carcinoma
- What is being tested?
- Zirconium 89Zr crefmirlimab berdoxam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Feb 2023to 31 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Positron Emission Tomography Repeatability Evaluation of Tissue Zirconium 89Zr Crefmirlimab Berdoxam
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
- Being tested
- Zirconium 89Zr crefmirlimab berdoxam
- Medical subject headings
- Melanoma, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconium 89Zr crefmirlimab berdoxamBiological
Also called Zr-89 Df-crefmirlimab, Zr-89 Df-IAB22M2C
Zirconium-89 labelled minibody for whole body PET imaging to visualize CD8+ cell distribution.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Zirconium 89Zr crefmirlimab berdoxam |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVs in tumor
Absolute and relative difference in tumor SUVs
Measured: 2-4 weeks
SUVs in reference tissues
Absolute and relative difference in reference tissue SUVs
Measured: 2-4 weeks
ratio of tumor SUVs to reference tissue SUVs
Absolute and relative difference in SUV ratios
Measured: 2-4 weeks
Secondary outcomes (1)
Safety of repeat doses of Zr-89 crefmirlimab berdoxam
Adverse events collected during the trial and as self-reported events.
Measured: Through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start16 Feb 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Why it stopped: Strategic decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImaginAb, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Hull
- Responsible party
- Sponsor
- Investigators
- Azeem Saleem, MB BS DMRT PhD FRCR, Principal investigator, Castle Hill Hospital, Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744128
- Sponsor's protocol ID
- IAB-CD8-204
- Acronym
- PRETZCEL
- Status last verified
- Nov 2024
- First submitted
- 19 Jan 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography Repeatability Evaluation of Tissue Zirconium 89Zr Crefmirlimab Berdoxam
- ClinicalTrials.gov ID
- NCT05744128
- Acronym / sponsor ID
- PRETZCEL / IAB-CD8-204
- Conditions
- Melanoma, Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic decision
- Enrolment
- 3 participants (actual)
- Lead sponsor
- ImaginAb, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Hull
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Biological: Zirconium 89Zr crefmirlimab berdoxamEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zirconium 89Zr crefmirlimab berdoxamAlso: Zr-89 Df-crefmirlimab, Zr-89 Df-IAB22M2CZirconium-89 labelled minibody for whole body PET imaging to visualize CD8+ cell distribution. | Biological | Single Arm |
Primary outcome
SUVs in tumor
Time frame: 2-4 weeks
Absolute and relative difference in tumor SUVs
SUVs in reference tissues
Time frame: 2-4 weeks
Absolute and relative difference in reference tissue SUVs
ratio of tumor SUVs to reference tissue SUVs
Time frame: 2-4 weeks
Absolute and relative difference in SUV ratios
1 secondary outcome
Safety of repeat doses of Zr-89 crefmirlimab berdoxam
Time frame: Through study completion, an average of 8 weeks
Results and safety
The study was stopped early (reason given: Strategic decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Melanoma
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
Enrolling by invitationObservational study
Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
Melanoma, Adenocarcinoma
Active, not recruitingPhase 2
A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma
Acral Lentiginous Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8
RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
RecruitingEarly Phase 1
177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors
PDL1 Gene Mutation, Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azeem Saleem, MB BS DMRT PhD FRCR principal investigator
Castle Hill Hospital, Hull
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zirconium 89Zr crefmirlimab berdoxam in people with Melanoma and Renal Cell Carcinoma, run by ImaginAb, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Strategic decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVs in tumor (time frame: 2-4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024; AzTrials last refreshed its copy on 3 Nov 2026.