Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies (iPREDICT)
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ClinicalTrials.gov Identifier: NCT05013099 |
Recruitment Status :
Recruiting
First Posted : August 19, 2021
Last Update Posted : January 25, 2023
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Condition or disease | Intervention/treatment | Phase |
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Melanoma Merkel Cell Carcinoma, Unspecified Renal Cell Carcinoma Non Small Cell Lung Cancer | Biological: zirconium Zr 89 crefmirlimab berdoxam | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | A Phase IIB, Open Label, Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies, Scheduled to Receive Immunotherapy (IOT) as a Single Agent or Combination, to Predict Response to Therapy |
Actual Study Start Date : | December 9, 2021 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | December 2024 |

Arm | Intervention/treatment |
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Experimental: Subjects with melanoma, Merkel cell, renal cell, or NSCLC
Eligible subjects will receive up to three 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 3.0 mCi ± 20% and 4.5 mg API) as an IV infusion or slow bolus injection as follows: First scan within 14 days prior to the onset of IOT, and a second scan 4 to 6 weeks after start of immunotherapy. The second zirconium Zr 89 crefmirlimab berdoxam administration and scan should be completed prior to the start of the third cycle of IOT. Subjects who are determined by the treating physician to have PD on immunotherapy can receive the optional third zirconium Zr 89 crefmirlimab berdoxam PET scan at the principal investigator's (PI's) discretion.
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Biological: zirconium Zr 89 crefmirlimab berdoxam
Up to three 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 3.0 mCi ± 20% and 4.5 mg API) as an IV infusion or slow bolus injection as follows: First (PETbaseline) within 14 days prior to the onset of IOT, and a second (PETEOC1) 4 to 6 weeks after start of immunotherapy. The second zirconium Zr 89 crefmirlimab berdoxam administration and scan (PETEOC1) should be completed prior to the start of the third cycle of IOT. Subjects who are determined by the treating physician to have PD on immunotherapy can receive the optional third zirconium Zr 89 crefmirlimab berdoxam PET scan at the principal investigator's (PI's) discretion.
Other Names:
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- Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 tomography/computed tomography (PET/CT) [ Time Frame: Baseline to at least 24 or 27 weeks after the start of IOT, depending on treatment schedule. ]Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 from 3 (or up to 3) consecutive imaging assessments (CT and/or MRI) following onset of immuno-oncology treatment.
- Largest measured difference from baseline in the lesion major axis from three (or up to three) consecutive standard of care imaging assessments (CT and/or MRI) [ Time Frame: Baseline to at least 24 or 27 weeks after the start IOT, depending on treatment schedule. ]Largest measured difference from baseline in the lesion major axis from three (or up to three) consecutive standard of care imaging assessments (CT and/or MRI) following onset of immuno-oncology treatment.
- Incidence and severity of AEs [ Time Frame: Up to 48 weeks or end of treatment. ]Incidence and severity of AEs
- Incidence and severity of infusion or injection reactions [ Time Frame: 33 days post infusion ]Incidence and severity of infusion or injection reactions reported during or shortly after administration of the investigational product.
- Incidence of withdrawal from scanning protocol due to zirconium Zr 89 crefmirlimab berdoxam related AEs [ Time Frame: Up to 48 weeks or end of treatment ]Incidence of withdrawal from scanning protocol due to zirconium Zr 89 crefmirlimab berdoxam related AEs
- 12-lead ECG ventricular rate (bpm) [ Time Frame: baseline to 48 weeks or end of study ]Ventricular rate (bpm) will be recorded from the 12-lead ECG
- 12-lead ECG PR interval (msec) [ Time Frame: baseline to 48 weeks or end of study ]PR interval (msec) will be recorded from the 12-lead ECG
- 12-lead ECG QRS interval (msec) [ Time Frame: baseline to 48 weeks or end of study ]QRS interval (msec) will be recorded from the 12-lead ECG
- 12-lead ECG QT interval (msec) [ Time Frame: baseline to 48 weeks or end of study ]QT interval (msec) will be recorded from the 12-lead ECG
- 12-lead ECG QTc interval (msec) [ Time Frame: baseline to 48 weeks or end of study ]QTc interval (msec) will be recorded from the 12-lead ECG
- 12-lead ECG Overall Result [ Time Frame: baseline to 48 weeks or end of study ]Investigator's overall assessment of the ECG reading will be recorded as normal or abnormal. If abnormal, as either "not clinically significant" or "clinically significant"
- Anti-drug antibody [ Time Frame: baseline to 48 weeks or end of study ]Detection of anti-drug antibodies
- Change in blood AST levels (U/L) from baseline. [ Time Frame: Baseline through 48 weeks or end of treatment. ]Blood AST levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
- Change in blood ALT levels (U/L) from baseline. [ Time Frame: Baseline through 48 weeks or end of treatment. ]Blood ALT levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
- Change in blood ALP levels (U/L) from baseline. [ Time Frame: Baseline through 48 weeks or end of treatment. ]Blood ALP levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
- Change in blood bilirubin levels (mg/dL) from baseline. [ Time Frame: Baseline through 48 weeks or end of treatment. ]Blood bilirubin levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
- Change in blood LDH levels (U/L) from baseline. [ Time Frame: Baseline through 48 weeks or end of treatment. ]Blood LDH levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
- Change in blood BUN levels (mg/dL) from baseline. [ Time Frame: Baseline through 48 weeks or end of treatment. ]Blood BUN levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
- Change in blood GGT levels (U/L) from baseline. [ Time Frame: Baseline through 48 weeks or end of treatment. ]Blood GGT levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
- Change in serum creatinine levels (mg/dL) from baseline. [ Time Frame: Baseline through 48 weeks or end of treatment. ]Serum creatinine levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
- Change in blood uric acid levels (mg/dL) from baseline. [ Time Frame: Baseline through 48 weeks or end of treatment. ]Blood uric acid levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
- Change in blood sodium levels (mmol/L) from baseline. [ Time Frame: Baseline through 48 weeks or end of treatment. ]Blood sodium (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
- Change in blood potassium levels (mmol/L) from baseline. [ Time Frame: Baseline through 48 weeks or end of treatment. ]Blood potassium (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
- Change in blood chloride levels (mmol/L) from baseline. [ Time Frame: Baseline through 48 weeks or end of treatment. ]Blood chloride (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
- Change in blood glucose levels (mg/dL) from baseline. [ Time Frame: Baseline through 48 weeks or end of treatment. ]Blood glucose (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
- Evaluate zirconium Zr 89 crefmirlimab berdoxam PET/CT as a discriminator of pseudo-progression. [ Time Frame: Up to 48 weeks or end of treatment. ]Incidence of iRECIST defined pseudo-progression events.
- Evaluate zirconium Zr 89 crefmirlimab berdoxam PET/CT in subjects who develop clinical and/or radiographic progression to explore mechanisms for treatment resistance. [ Time Frame: Up to 48 weeks or end of treatment. ]RECIST 1.1 defined Progressive Disease.
- Evaluate zirconium Zr 89 crefmirlimab berdoxam PET/CT as a predictor or surrogate for IOT immune related adverse events (irAEs). [ Time Frame: Up to 48 weeks or end of treatment. ]Incidence of Immuno-oncology related TEAEs in non-diseased tissues and organs.
- Correlate zirconium Zr 89 crefmirlimab berdoxam PET uptake with CD8 expression and PD 1/PD-L1 expression as determined by immunohistochemistry (IHC). [ Time Frame: Up to 48 weeks or end of treatment. ]CD8 expressing cells and PD-1/PD-L1 expressing cells.
- Evaluate zirconium Zr 89 crefmirlimab berdoxam PET/CT as a predictor of progression free survival (PFS) [ Time Frame: Up to 48 weeks or end of treatment. ]Patient level Progression Free Survival.
- Evaluate zirconium Zr 89 crefmirlimab berdoxam PET/CT as a predictor of duration of response (DoR). [ Time Frame: Up to 48 weeks or end of treatment. ]Patient level Duration of Response.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Subjects will be eligible for enrollment in the study if they meet ONE criteria a, b or c in point 1 and ALL the criteria in points 2-9.
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Subjects must meet ONE of the criteria a, b or c below:
- For enrollment into Cohort A: Subjects with histologically confirmed advanced or metastatic non-uveal/non-mucosal melanoma or merkel cell carcinoma (MCPyV positive and negative) who are not amenable to surgical cure and are candidates to receive single- or combined IOT alone (not to include cytotoxic chemotherapy) as first or second line treatment.
- For enrollment into Cohort B: Subjects with histologically confirmed advanced or metastatic clear cell Renal Cell Carcinoma as defined on pathologic examination by a component of clear cell, who are not amenable to surgical cure and are candidates to receive single- or combined IOT alone or IOT in combination with VEGFR-directed or tyrosine kinase inhibitor (not to include cytotoxic chemotherapy) as first or second line treatment
- For enrollment into Cohort C: Subjects with histologically confirmed advanced or metastatic non-small cell lung cancer without non-smoker/driver mutations who have a PD-L1 expression ≥ 50% tumor cells (TC), are not amenable to surgical cure, and are candidates to receive single- or combined IOT alone (not to include cytotoxic chemotherapy) as first or second line treatment as per the label/prescribing information at the physicians discretion.
Subjects must meet All of the criteria 2-9 below:
- At least 1 RECIST 1.1-measurable. non-irradiated, non-osseous (unless there is an associated measurable soft-tissue component) lesion documented on intravenous (IV) contrast-enhanced CT or MRI (per RECIST criteria 1.1) prior to first zirconium Zr 89 crefmirlimab berdoxam administration.
- Has an adequate amount of time between their prior treatment/procedure and the 1st administration of zirconium Zr 89 crefmirlimab berdoxam.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and anticipated survival of at least 6 months.
- Meeting all clinical safety lab values per institution's SOC, or investigator's discretion, for subjects receiving cancer treatment.
- Male or female age ≥18 years.
- Ability to understand the purposes and risks of the trial and has signed an Institutional Review Board (IRB) approved informed consent form.
- Willingness and ability to comply with all protocol required procedures.
- For men and women of child-producing potential, use of effective double barrier contraceptive methods during the study, up to 30 days after the last administration of the investigational product.
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Exclusion Criteria:
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Subjects will NOT be eligible for enrollment in the study if they meet ANY of the following criteria:
- Bone-only disease without a measurable soft tissue component on conventional imaging (MRI, PET, CT).
- Subjects with skin-only (cutaneous) lesions will be excluded from the tumor biopsy assessment.
- Serious nonmalignant disease, additional active malignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
- Subjects with splenic dysfunction or who are status post splenectomy. Post-splenectomy subjects who develop an accessory spleen with clinical and radiographic evidence of splenic function will be allowed with prior approval from the Sponsor.
- Corticosteroid therapy is prohibited if used for the treatment of inflammatory or autoimmune conditions. Patients with adrenal insufficiency from prior surgery or immunotherapy toxicity may be on standard chronic replacement doses of hydrocortisone that also require sporadic use of stress doses of steroid .
- Pregnant women or nursing mothers.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05013099
Contact: Katherine Young | +1-310-645-1211 | kyoung@imaginab.com | |
Contact: Michael Ferris, PhD | mferris@imaginab.com |
United States, Arkansas | |
CARTI Cancer Center | Recruiting |
Little Rock, Arkansas, United States, 72205 | |
Contact: Kelsey Williams kelsey.williams@carti.com | |
Principal Investigator: David Hays, MD | |
United States, California | |
City of Hope | Recruiting |
Duarte, California, United States, 91010 | |
Contact: Jennifer Simpson jsimpson@coh.org | |
Principal Investigator: Jeffrey Wong, MD | |
Providence Saint John's Cancer Institute | Recruiting |
Santa Monica, California, United States, 90404 | |
Contact: Kelly Garver kelly.garver@providence.org | |
Principal Investigator: Kim Margolin, MD | |
United States, Texas | |
UT Southwestern Medical Center | Recruiting |
Dallas, Texas, United States, 75390 | |
Contact: Vida Rhodes vida.rhodes@utsouthwestern.edu | |
Principal Investigator: James Brugarolas, MD | |
United States, Washington | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98109 | |
Contact: Elsa Roberts, MD erobert3@fredhutch.org | |
Principal Investigator: Delphine Chen, MD | |
Australia, New South Wales | |
Macquarie University Hospital | Recruiting |
Macquarie Park, New South Wales, Australia, 2109 | |
Contact: Harrison O'Brien harrison.obrien@mq.edu.au | |
Principal Investigator: Alison Zhang, MD | |
Australia, Queensland | |
Princess Alexandra Hospital | Recruiting |
Woolloongabba, Queensland, Australia | |
Contact: Maria Vatca maria.vatca@tri.edu.au | |
Principal Investigator: Wen Xu, MD | |
Australia, South Australia | |
Royal Adelaide Hospital | Recruiting |
Adelaide, South Australia, Australia, 5000 | |
Contact: Jesikah Logan jesikah.logan@sa.gov.au | |
Principal Investigator: Michael Brown, MD | |
Australia, Victoria | |
Olivia Newton-John Cancer Research Insititute | Not yet recruiting |
Heidelberg, Victoria, Australia, 3084 | |
Contact: Tina Chen tina.chen@austin.org.au | |
Principal Investigator: Andrew Scott, MD | |
Peter MacCallum Cancer Centre | Recruiting |
Melbourne, Victoria, Australia | |
Contact: Leeanne Pasanen leeanne.pasanen@petermac.org | |
Principal Investigator: Ramin Alipour | |
Belgium | |
University Hospitals Leuven | Recruiting |
Leuven, Belgium | |
Principal Investigator: Christophe Deroose, MD | |
Netherlands | |
Radboud University Medical Center | Recruiting |
Nijmegen, Gelderland, Netherlands, 6525 | |
Contact: Michel de Groot michel.degroot@radboudumc.nl | |
Principal Investigator: Erik Aarntzen, MD | |
Leiden University Medical Center | Recruiting |
Leiden, Netherlands | |
Principal Investigator: Ellen Kapiteijn, MD | |
Switzerland | |
Lausanne University Hospital | Recruiting |
Lausanne, Switzerland | |
Principal Investigator: Niklaus Schaefer | |
United Kingdom | |
Northern Centre for Cancer Care and Newcastle University | Recruiting |
Newcastle Upon Tyne, United Kingdom | |
Principal Investigator: Rachel Pearson, MD |
Principal Investigator: | Kim Margolin, MD | Providence Saint John's Cancer Institute |
Responsible Party: | ImaginAb, Inc. |
ClinicalTrials.gov Identifier: | NCT05013099 |
Other Study ID Numbers: |
IAB-CD8-203 |
First Posted: | August 19, 2021 Key Record Dates |
Last Update Posted: | January 25, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma, Merkel Cell Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Adenocarcinoma |
Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Polyomavirus Infections DNA Virus Infections Virus Diseases Infections Tumor Virus Infections Carcinoma, Neuroendocrine |