Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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 : Not yet recruiting
First Posted : August 19, 2021
Last Update Posted : August 19, 2021
Sponsor:
Collaborator:
City of Hope Medical Center
Information provided by (Responsible Party):
ImaginAb, Inc.

Brief Summary:
The purpose of this study is to evaluate whether 89Zr-Df-crefmirlimab PET 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
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : May 2022


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. Evaluate the performance of 89Zr Df crefmirlimab positron emission tomography/computed tomography (PET/CT) for predicting patient response to immunotherapy. [ Time Frame: Baseline to at least 24 or 27 weeks after the start 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. Evaluate the performance of 89Zr Df crefmirlimab PET/CT for predicting lesion response to immunotherapy. [ 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. To assess safety of the repeat 89Zr Df crefmirlimab infusions. [ Time Frame: Up to 48 weeks or end of treatment. ]
    Incidence and severity of AEs, infusion reactions, labs, and ECGs. Number of subjects withdrawn due AEs. Appearance of anti-drug antibodies.


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

Locations
Layout table for location information
United States, California
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States, 91010
Sponsors and Collaborators
ImaginAb, Inc.
City of Hope Medical Center
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: August 19, 2021
Last Verified: August 2021
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