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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05013099
Additional trial details provided through ANZCTR are available at the end of this record.
Registration number
NCT05013099
Ethics application status
Date submitted
30/07/2021
Date registered
19/08/2021
Titles & IDs
Public title
Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies
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Scientific 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
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Secondary ID [1]
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IAB-CD8-203
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Universal Trial Number (UTN)
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Trial acronym
iPREDICT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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0
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Merkel Cell Carcinoma, Unspecified
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0
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Renal Cell Carcinoma
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Non Small Cell Lung Cancer
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0
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Condition category
Condition code
Cancer
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0
0
0
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Malignant melanoma
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Cancer
0
0
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0
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Non melanoma skin cancer
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Cancer
0
0
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0
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - zirconium Zr 89 crefmirlimab berdoxam
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.
Treatment: Other: 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.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to at least 24 or 27 weeks after the start of IOT, depending on treatment schedule.
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Secondary outcome [1]
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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)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to at least 24 or 27 weeks after the start IOT, depending on treatment schedule.
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Secondary outcome [2]
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Incidence and severity of AEs
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Assessment method [2]
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Incidence and severity of AEs
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Timepoint [2]
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Up to 48 weeks or end of treatment.
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Secondary outcome [3]
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Incidence and severity of infusion or injection reactions
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Assessment method [3]
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Incidence and severity of infusion or injection reactions reported during or shortly after administration of the investigational product.
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Timepoint [3]
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33 days post infusion
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Secondary outcome [4]
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Incidence of withdrawal from scanning protocol due to zirconium Zr 89 crefmirlimab berdoxam related AEs
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Assessment method [4]
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Incidence of withdrawal from scanning protocol due to zirconium Zr 89 crefmirlimab berdoxam related AEs
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Timepoint [4]
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Up to 48 weeks or end of treatment
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Secondary outcome [5]
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12-lead ECG ventricular rate (bpm)
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Assessment method [5]
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Ventricular rate (bpm) will be recorded from the 12-lead ECG
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Timepoint [5]
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baseline to 48 weeks or end of study
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Secondary outcome [6]
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12-lead ECG PR interval (msec)
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Assessment method [6]
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PR interval (msec) will be recorded from the 12-lead ECG
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Timepoint [6]
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baseline to 48 weeks or end of study
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Secondary outcome [7]
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12-lead ECG QRS interval (msec)
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Assessment method [7]
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QRS interval (msec) will be recorded from the 12-lead ECG
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Timepoint [7]
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baseline to 48 weeks or end of study
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Secondary outcome [8]
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12-lead ECG QT interval (msec)
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Assessment method [8]
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QT interval (msec) will be recorded from the 12-lead ECG
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Timepoint [8]
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baseline to 48 weeks or end of study
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Secondary outcome [9]
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12-lead ECG QTc interval (msec)
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Assessment method [9]
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QTc interval (msec) will be recorded from the 12-lead ECG
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Timepoint [9]
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baseline to 48 weeks or end of study
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Secondary outcome [10]
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12-lead ECG Overall Result
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Assessment method [10]
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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"
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Timepoint [10]
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baseline to 48 weeks or end of study
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Secondary outcome [11]
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Anti-drug antibody
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Assessment method [11]
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Detection of anti-drug antibodies
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Timepoint [11]
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baseline to 48 weeks or end of study
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Secondary outcome [12]
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Change in blood AST levels (U/L) from baseline.
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Assessment method [12]
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Blood AST levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
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Timepoint [12]
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Baseline through 48 weeks or end of treatment.
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Secondary outcome [13]
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Change in blood ALT levels (U/L) from baseline.
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Assessment method [13]
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Blood ALT levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
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Timepoint [13]
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Baseline through 48 weeks or end of treatment.
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Secondary outcome [14]
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Change in blood ALP levels (U/L) from baseline.
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Assessment method [14]
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Blood ALP levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
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Timepoint [14]
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Baseline through 48 weeks or end of treatment.
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Secondary outcome [15]
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Change in blood bilirubin levels (mg/dL) from baseline.
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Assessment method [15]
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Blood bilirubin levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
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Timepoint [15]
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Baseline through 48 weeks or end of treatment.
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Secondary outcome [16]
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Change in blood LDH levels (U/L) from baseline.
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Assessment method [16]
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Blood LDH levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
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Timepoint [16]
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Baseline through 48 weeks or end of treatment.
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Secondary outcome [17]
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Change in blood BUN levels (mg/dL) from baseline.
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Assessment method [17]
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Blood BUN levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
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Timepoint [17]
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Baseline through 48 weeks or end of treatment.
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Secondary outcome [18]
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Change in blood GGT levels (U/L) from baseline.
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Assessment method [18]
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Blood GGT levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
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Timepoint [18]
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Baseline through 48 weeks or end of treatment.
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Secondary outcome [19]
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Change in serum creatinine levels (mg/dL) from baseline.
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Assessment method [19]
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Serum creatinine levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
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Timepoint [19]
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Baseline through 48 weeks or end of treatment.
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Secondary outcome [20]
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Change in blood uric acid levels (mg/dL) from baseline.
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Assessment method [20]
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Blood uric acid levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
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Timepoint [20]
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Baseline through 48 weeks or end of treatment.
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Secondary outcome [21]
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Change in blood sodium levels (mmol/L) from baseline.
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Assessment method [21]
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Blood sodium (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
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Timepoint [21]
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Baseline through 48 weeks or end of treatment.
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Secondary outcome [22]
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Change in blood potassium levels (mmol/L) from baseline.
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Assessment method [22]
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Blood potassium (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
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Timepoint [22]
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Baseline through 48 weeks or end of treatment.
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Secondary outcome [23]
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Change in blood chloride levels (mmol/L) from baseline.
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Assessment method [23]
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Blood chloride (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
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Timepoint [23]
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Baseline through 48 weeks or end of treatment.
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Secondary outcome [24]
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Change in blood glucose levels (mg/dL) from baseline.
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Assessment method [24]
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Blood glucose (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
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Timepoint [24]
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Baseline through 48 weeks or end of treatment.
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Eligibility
Key inclusion criteria
* 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.
1. Subjects must meet ONE of the criteria a, b or c below:
1. 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.
2. For enrollment into Cohort B: Subjects with histologically confirmed advanced or metastatic clear cell Renal Cell Carcinoma or Renal Cell Carcinoma with sarcomatoid features (regardless of subtype) as defined on pathologic examination by a component of clear cell or sarcomatoid, 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
3. For enrollment into Cohort C: Subjects with histologically confirmed advanced or metastatic non-small cell lung cancer without non-smoker/driver mutations 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 as per the label/prescribing information at the physicians discretion.
i. Patients with driver mutations that are expected to show significant benefit from first line checkpoint inhibiter treatment (such as KRAS G12C mutations) are eligible if all other I/E criteria are met
Subjects must meet All of the criteria 2-9 below:
2. 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.
3. Has an adequate amount of time between their prior treatment/procedure and the 1st administration of zirconium Zr 89 crefmirlimab berdoxam.
4. Eastern Cooperative Oncology Group (ECOG) performance status =2 and anticipated survival of at least 6 months.
5. Meeting all clinical safety lab values per institution's SOC, or investigator's discretion, for subjects receiving cancer treatment.
6. Male or female age =18 years.
7. Ability to understand the purposes and risks of the trial and has signed an Institutional Review Board (IRB) approved informed consent form.
8. Willingness and ability to comply with all protocol required procedures.
9. 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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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Subjects will NOT be eligible for enrollment in the study if they meet ANY of the following criteria:
1. Bone-only disease without a measurable soft tissue component on conventional imaging (MRI, PET, CT).
2. Subjects with skin-only (cutaneous) lesions will be excluded from the tumor biopsy assessment.
3. Serious nonmalignant disease, additional active malignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
4. 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.
5. 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 .
6. Pregnant women or nursing mothers.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/12/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
70
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Macquarie University Hospital - Macquarie Park
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Recruitment hospital [2]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [3]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [4]
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Olivia Newton-John Cancer Research Insititute - Heidelberg
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Recruitment hospital [5]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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2109 - Macquarie Park
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Recruitment postcode(s) [2]
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- Woolloongabba
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment postcode(s) [5]
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- Melbourne
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
Arkansas
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
New York
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Texas
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Washington
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Country [6]
0
0
Belgium
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State/province [6]
0
0
Leuven
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Country [7]
0
0
Netherlands
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State/province [7]
0
0
Gelderland
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Country [8]
0
0
Netherlands
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State/province [8]
0
0
Leiden
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Country [9]
0
0
Switzerland
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State/province [9]
0
0
Lausanne
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Country [10]
0
0
United Kingdom
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State/province [10]
0
0
Newcastle Upon Tyne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
ImaginAb, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate whether zirconium Zr 89 crefmirlimab berdoxam (other names 89Zr-crefmirlimab berdoxam, 89Zr-Df-crefmirlimab, 89Zr-Df-IAB22M2C) PET/CT can predict the response of advanced or metastatic melanoma, Merkel cell carcinoma, renal cell carcinoma, or non-small cell lung cancer tumors to immuno-oncology therapy.
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Trial website
https://clinicaltrials.gov/study/NCT05013099
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Kim Margolin, MD
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Address
0
0
Providence Saint John's Cancer Institute
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Kristin Schmiedehausen, MD
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Address
0
0
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Country
0
0
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Phone
0
0
+1-650-833-8819
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05013099
Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
VIC
Recruitment hospital [1]
35
Austin Health - Austin Hospital
Recruitment hospital [2]
46
Peter MacCallum Cancer Centre
Recruitment postcode(s) [1]
40
3084
Recruitment postcode(s) [2]
51
3000
Funding & Sponsors
Primary sponsor
Commercial sector/Industry
Primary sponsor name
ImaginAb, Inc.
Primary sponsor address
423 Hindry Ave. Suite D
Inglewood, CA 90301 USA
Primary sponsor country
United States of America
Ethics approval
Ethics application status
Approved
Ethics committee name [1]
31
St Vincent's Hospital (Melbourne) Human Research
Address [1]
31
41 Victoria Parade, Fitzroy, VIC 3065
Country [1]
31
Australia
Date submitted for ethics approval [1]
31
30/07/2021
Approval date [1]
31
02/09/2021
Ethics approval number [1]
31
Public notes
Contacts
Principal investigator
Title
261
0
Prof
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Name
261
0
Andrew Scott
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Address
261
0
145 Studley Rd, Heidelberg VIC 3084
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Country
261
0
Australia
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Phone
261
0
0394965088
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Fax
261
0
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Email
261
0
[email protected]
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Contact person for public queries
Title
262
0
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Name
262
0
Katherine Young
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Address
262
0
423 Hindry Ave. Suite D, Inglewood, CA 90301
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Country
262
0
United States of America
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Phone
262
0
+1 310 645 1211
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Fax
262
0
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Email
262
0
[email protected]
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Contact person for scientific queries
Title
263
0
Prof
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Name
263
0
Andrew Scott
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Address
263
0
145 Studley Rd, Heidelberg VIC 3084
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Country
263
0
Australia
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Phone
263
0
0394965088
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Fax
263
0
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Email
263
0
[email protected]
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