Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 14 for:    iab22M2C OR crefmirlimab

Study of 89Zr-Df-crefmirlimab PET/CT in Subjects With Advanced or Metastatic Malignancies (iPREDICT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05013099
Recruitment Status : Recruiting
First Posted : August 19, 2021
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
ImaginAb, Inc.

Brief Summary:
The purpose of this study is to evaluate whether 89Zr-Df-crefmirlimab (other names 89Zr-crefmirlimab berdoxam and 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: 89Zr-Df-Crefmirlimab Phase 2

Layout table for study information
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 89Zr-Df-Crefmirlimab 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 : March 2023
Estimated Study Completion Date : May 2023


Arm Intervention/treatment
Experimental: Subjects with melanoma, Merkel cell, renal cell, or NSCLC
Eligible subjects will receive up to three 89Zr-Df-crefmirlimab 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 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 89Zr-Df-crefmirlimab infusion 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 89Zr-Df-crefmirlimab PET scan at the principal investigator's (PI's) discretion.
Biological: 89Zr-Df-Crefmirlimab
Up to three 89Zr-Df-crefmirlimab 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 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 89Zr-Df-crefmirlimab infusion 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 89Zr-Df-crefmirlimab PET scan at the principal investigator's (PI's) discretion.




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 reactions [ Time Frame: 33 days post infusion ]
    Incidence and severity of infusion reactions reported during or shortly after infusion of the investigational product.

  4. Incidence of withdrawal from scanning protocol due to 89Zr-Df-crefmirlimab related AEs [ Time Frame: Up to 48 weeks or end of treatment ]
    Incidence of withdrawal from scanning protocol due to 89Zr-Df-crefmirlimab 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 infusion and 60 minutes post infusion.

  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 infusion and 60 minutes post infusion.

  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 infusion and 60 minutes post infusion.

  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 infusion and 60 minutes post infusion.

  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 infusion and 60 minutes post infusion.

  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 infusion and 60 minutes post infusion.

  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 infusion and 60 minutes post infusion.

  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 infusion and 60 minutes post infusion.

  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 infusion and 60 minutes post infusion.

  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 infusion and 60 minutes post infusion.

  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 infusion and 60 minutes post infusion.

  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 infusion and 60 minutes post infusion.

  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 infusion and 60 minutes post infusion.


Other Outcome Measures:
  1. Evaluate 89Zr-Df-crefmirlimab 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 89Zr-Df-crefmirlimab 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 89Zr-Df-crefmirlimab 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 89Zr-Df-crefmirlimab 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 89Zr-Df-crefmirlimab 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 89Zr-Df-crefmirlimab 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.


Layout table for eligibility information
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 line treatment.
      2. For enrollment into Cohort B: Subjects with histologically confirmed advanced or metastatic nonpapillary Renal Cell Carcinoma who are not amenable to surgical cure and are candidates to receive single- or combined IOT alone or IOT in combination with 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-smokers/driver mutations who are not amenable to surgical cure and are candidates to receive Atezolizumab as a monotherapy for first line treatment.

      Subjects must meet All of the criteria 2-9 below:

    2. At least 1 RECIST 1.1-measurable. non-irradiated, non-cutaneous, 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 89Zr-Df-crefmirlimab infusion.
    3. Has an adequate washout period before the date of consent as defined by:
    4. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and anticipated survival of at least 6 months.
    5. Subject must be IOT naïve.
    6. Meeting all clinical safety lab values per institution's SOC, or investigator's discretion, for subjects receiving cancer treatment.
    7. Male or female age ≥18 years.
    8. Ability to understand the purposes and risks of the trial and has signed an Institutional Review Board (IRB) approved informed consent form.
    9. Willingness and ability to comply with all protocol required procedures.
    10. 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 on conventional imaging (MRI, PET, CT) or skin- only lesions.
    2. Serious nonmalignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
    3. Subjects with splenic dysfunction or who are status post splenectomy will be discussed on a case-by-case basis due to the importance of the spleen in CD8 imaging as a reference tissue.
    4. 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
Layout table for location contacts
Contact: Katherine Young +1-310-645-1211 kyoung@imaginab.com
Contact: Michael Ferris, PhD mferris@imaginab.com

Locations
Layout table for location information
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
HOAG Cancer Center Recruiting
Irvine, California, United States, 92618
Contact: Beth Thomsen       beth.thomsen@hoag.org   
Principal Investigator: Gary Ulaner, MD         
St. John's Cancer Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Irving Ledesma       irving.ledesmaprado@providence.org   
Principal Investigator: Kim Margolin, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98109
Contact: Delphine Chen, MD       dlchen7@uw.edu   
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, 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
Principal Investigator: Andrew Scott, MD         
Netherlands
Radboud University Medical Center Recruiting
Nijmegen, Gelderland, Netherlands, 6525
Contact: Michel de Groot       michel.degroot@radboudumc.nl   
Principal Investigator: Erik Aarntzen, MD         
Sponsors and Collaborators
ImaginAb, Inc.
Layout table for additonal information
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: July 13, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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