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Trial record 1 of 1 for:    05013099
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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
Sponsor:
Information provided by (Responsible Party):
ImaginAb, Inc.

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.

Condition or disease Intervention/treatment Phase
Melanoma Merkel Cell Carcinoma, Unspecified Renal Cell Carcinoma Non Small Cell Lung Cancer Biological: zirconium Zr 89 crefmirlimab berdoxam Phase 2

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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
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.
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:
  • 89Zr-Df-crefmirlimab
  • 89Zr-Df-IAB22M2C




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Incidence and severity of AEs [ Time Frame: Up to 48 weeks or end of treatment. ]
    Incidence and severity of AEs

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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"

  11. Anti-drug antibody [ Time Frame: baseline to 48 weeks or end of study ]
    Detection of anti-drug antibodies

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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
      3. 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:

    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.

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Katherine Young +1-310-645-1211 kyoung@imaginab.com
Contact: Michael Ferris, PhD mferris@imaginab.com

Locations
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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         
Sponsors and Collaborators
ImaginAb, Inc.
Investigators
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Principal Investigator: Kim Margolin, MD Providence Saint John's Cancer Institute
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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