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⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for PET/CT in Patients With Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT03802123
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
ImaginAb, Inc.

Brief Summary:
Protocol IAB-CD8-201 is a Phase II, Open Label, Multi-Dose Study of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for Positron Emission Tomography (PET/CT) in Patients with Advanced or Metastatic Melanoma, Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck Selected to Receive Standard-of-Care Immunotherapy as Single Agent or in Combination. This study will evaluate the safety of repeat doses of ⁸⁹Zr-Df-IAB22M2C, assess and quantify any detectable changes in ⁸⁹Zr-Df-IAB22M2C uptake from Baseline to post-Treatment, establish the relationship of ⁸⁹Zr-Df-IAB22M2C uptake in tumors with CD8+ TIL density, biodistribution, evaluate the variance in participants' gene expression pre- and post-Treatment, evaluate the correlation of ⁸⁹Zr-Df-IAB22M2C uptake with clinical response by RECIST 1.1/iRECIST and evaluate the correlation of ⁸⁹Zr-Df-IAB22M2C uptake with immune infiltrates and other molecular biomarkers (CD4, CD8, PD-1 and PD-L1) expression by IHC.

Condition or disease Intervention/treatment Phase
Positron-Emission Tomography Metastatic Solid Tumors Drug: ⁸⁹Zr-Df-IAB22M2C Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase II, Open Label, Multi-Dose Study OF ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for Positron Emission Tomography (PET/CT) in Patients With Advanced or Metastatic Melanoma, Non Small Cell Lung Cancer, Renal Cell Carcinoma or Squamous Cell Carcinoma of the Head and Neck Selected to Receive Standard-of-Care Immunotherapy As Single Agent or in Combination
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021


Arm Intervention/treatment
Experimental: ⁸⁹Zr-Df-IAB22M2C Infusion
A dose of 3 mCi (±20%) of ⁸⁹Zr-Df-IAB22M2C between 0.5 mg to 1.5 mg of API will be administered intravenously over 5-10 minutes, within one week prior to the onset of immunotherapy, and 5 to 6 weeks after start of IOT.
Drug: ⁸⁹Zr-Df-IAB22M2C
⁸⁹Zr-Df-IAB22M2C CD8 T cell tracer for Positron Emission Tomography (PET)




Primary Outcome Measures :
  1. Evaluate the safety and tolerability (incidence of adverse events) of repeat doses of ⁸⁹Zr-Df-IAB22M2C [ Time Frame: Time of infusion of ⁸⁹Zr-Df-IAB22M2C (Visit 2 Day 1) through 4-5 weeks after the second infusion of ⁸⁹Zr-Df-IAB22M2C ]
    The safety and tolerability of repeat doses of ⁸⁹Zr-Df-IAB22M2C will be assessed by incidence of adverse events per CTCAE criteria.

  2. ⁸⁹Zr-Df-IAB22M2C PET/CT images will be compared with CD8+ T cells density determined by IHC from biopsy samples [ Time Frame: Change from baseline to 2 weeks after the second infusion of ⁸⁹Zr-Df-IAB22M2C ]
    Analyze ⁸⁹Zr-Df-IAB22M2C uptake in biopsied tumors as determined by SUV-based quantitative measures with CD8+ TIL density determined by IHC from biopsy samples.


Secondary Outcome Measures :
  1. Assessment of Baseline and On-treatment ⁸⁹Zr-Df-IAB22M2C uptake and distribution in tumors and lymphoid organs, and measurement of change between the paired observations [ Time Frame: 5 weeks ]

    Assessment of Baseline and On-treatment ⁸⁹Zr-Df-IAB22M2C uptake and distribution in tumors and lymphoid organs, and measurement of change between the paired observations as determined by:

    • Tumor uptake analysis as described by visual scoring scales
    • Lymph node chain visibility defined as location and number of nodes in lymph node chains identified with elevated ⁸⁹Zr-Df-IAB22M2C activity.
    • SUV-based quantitative analysis (e.g. SUVmax, SUVpeak, SUVmean, CD8 tumor volume (volume of tumor tissues with increased CD8 uptake with SUV >40% SUVmax), and Tumor:Reference ratios
    • Visual and SUV-based quantitative analysis (e.g. SUVmax, SUVpeak, SUVmean) in tumor and reference tissue including lymph nodes, spleen, and bone marrow.

  2. Measurement of change in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) uptake in biopsied tumors as determined by SUV-based quantitative analysis [ Time Frame: 7 weeks ]
    Measurement of change in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) uptake in biopsied tumors as determined by SUV-based quantitative analysis (e.g. SUVmax, SUVpeak, SUVmean, CD8 tumor volume (volume of tumor tissues with increase CD8 uptake with SUV > 40% SUVmax) and Tumor: Reference ratio from Baseline to On- Treatment PET scans and correlation with change in CD8+ T cells as determined by IHC from biopsy samples obtained prior to and 4 to 7 weeks after the start of immunotherapy.

  3. Description of biodistribution patterns of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) on PETbaseline and PETTx and any changes in biodistribution between baseline and On-Treatment. [ Time Frame: 7 weeks ]
    Description of biodistribution patterns of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) on PETbaseline and PETTx and any changes in biodistribution between baseline and On-Treatment. PETbaseline and PETTx scans compared to change in CD8+ T cells in tumor lesions by IHC if the same lesion was biopsied at Baseline and On-Treatment visits


Other Outcome Measures:
  1. Evaluation of the variance in gene expression profiles in subjects prior to and On-treatment as measured in whole blood by Nanostring analysis. [ Time Frame: 7 weeks ]
    Evaluation of the variance in gene expression profiles in subjects prior to and On-treatment as measured in whole blood by Nanostring analysis.

  2. Correlation of visual and quantitative ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) uptake in tumor lesions with change in CD8+ T cells as determined by IHC from biopsy samples obtained prior to and 4 to 7 weeks after the start of immunotherapy. [ Time Frame: 7 weeks ]
    Correlation of visual and quantitative ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) uptake in tumor lesions with change in CD8+ T cells as determined by IHC from biopsy samples obtained prior to and 4 to 7 weeks after the start of immunotherapy.

  3. Estimation of positive predictive value, negative predictive value, sensitivity and specificity of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) PET for detecting CD8+ T cells as determined by IHC. [ Time Frame: 7 weeks ]
    Estimation of positive predictive value, negative predictive value, sensitivity and specificity of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) PET for detecting CD8+ T cells as determined by IHC.

  4. Assessment of changes in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) uptake and distribution from baseline to 5-7 days start of immunotherapy if available. [ Time Frame: 7 weeks ]
    Assessment of changes in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) uptake and distribution from baseline to 5-7 days start of immunotherapy if available.

  5. Correlation of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) uptake with clinical outcomes (response rates, duration of response, disease stability rate and PFS at defined intervals as determined by the local investigator. [ Time Frame: 18 months ]
    Correlation of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) uptake with clinical outcomes

  6. Correlation of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) uptake with radiologic responses [ Time Frame: 7 weeks ]

    Correlation of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) uptake with radiologic responses based upon:

    • Correlation of subject response by RECIST 1.1 compared to visual and quantitative SUVbased analysis
    • Correlation of RECIST target lesion response as determined by best change in lesion diameter while on immunotherapy compared to visual and quantitative SUV based analysis at baseline and On-treatment PET/CT scans.

  7. Correlation of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) tumor and lymph node uptake with immune infiltrates and other molecular biomarker (CD8) expression by IHC [ Time Frame: 7 weeks ]
    Correlation of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) tumor and lymph node uptake with immune infiltrates and other molecular biomarker (CD8) expression by IHC

  8. Correlation of the 89Zr-Df-IAB22M2C(CD8 PET Tracer) uptake on a subset of PETbaseline and PETtx scans that have been virtually reconstructed with lower theoretical doses of 8⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) with CD8+ T cells from IHC analysis. [ Time Frame: 7 weeks ]
    Correlation of the 89Zr-Df-IAB22M2C(CD8 PET Tracer) uptake on a subset of PETbaseline and PETtx scans that have been virtually reconstructed with lower theoretical doses of 8⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) with CD8+ T cells from IHC analysis.



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:

Participants will be eligible for enrollment in the study only if they meet ALL of the following criteria:

  1. 1. Patients with advanced or metastatic Melanoma, Non-Small Cell Lung Cancer, Renal Cell Carcinoma or Squamous Cell Carcinoma of the Head and Neck with at least one non-radiated lesion, who are scheduled to begin standard of care immunotherapy.
  2. • At least 1 non radiated measurable lesion documented on CT/, MRI (per RECIST criteria 1.1) or are FDG avid on FDG-PET within 45 days prior to first 89Zr-Df-IAB22M2C (CD8 PET Tracer) infusion.
  3. At least 1 non-cutaneous lesion that is accessible, per investigator's assessment, and eligible for biopsy. If only a single RECIST measurable lesion is present, investigator to determine if the tumor biopsy could interfere with RECIST assessments of response.
  4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  5. Meeting all clinical safety lab values per institution's standard of care, or Investigator's discretion, for patients receiving cancer treatment.
  6. Age ≥ 18 years.
  7. Ability to understand the purposes and risks of the trial and has signed an 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. Serious nonmalignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
  2. Patients with a single RECIST measurable lesion, biopsy of which, per investigator's assessment, is likely to interfere with RECIST assessments of response.
  3. Patients who have any splenic disorders, or had splenectomy, that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
  4. Pregnant women or nursing mothers.
  5. 5. Life expectancy < 6 months

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): NCT03802123


Contacts
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Contact: William Le, M.S. (310) 730-5812 wle@imaginab.com

Locations
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United States, Alabama
University of Alabama-Birmingham Hospital Recruiting
Birmingham, Alabama, United States, 35294
Contact: Jonathan McConathy, MD, PhD    205-996-7115    jmcconathy@uabmc.edu   
Principal Investigator: Jonathan McConathy, MD, PhD         
Sub-Investigator: William Carroll, MD         
Sub-Investigator: Eddy Yang, MD         
Sub-Investigator: Gagandeep Choudhary, MD         
Sub-Investigator: Marty Conry, MD         
Sub-Investigator: Pradeep Bhambhvani, MD         
Sub-Investigator: Lisle Nabell, MD         
Sub-Investigator: Sam Galgano, MD         
Sub-Investigator: Francisco Robert, MD         
Sub-Investigator: Janis O'Malley, MD         
Sub-Investigator: Sharon White, PhD         
Sub-Investigator: Suzy Lapi, PhD         
United States, Arkansas
CARTI Cancer Center Recruiting
Little Rock, Arkansas, United States, 72205
Contact: David Hays, MD    501-906-3000    david.hays@carti.com   
Principal Investigator: David Hays, MD         
Sub-Investigator: Jamie Burton, MD         
Sub-Investigator: Rhonda Gentry, MD         
Sub-Investigator: Ryan Hall, MD         
Sub-Investigator: Mariann Harrington, MD         
Sub-Investigator: Kewen Jauss, MD         
Sub-Investigator: Omer Khalil, MD         
Sub-Investigator: Lawrence Mendelsohn, MD         
Sub-Investigator: Balagopalan Nair, MD         
Sub-Investigator: Kamal Patel, MD         
Sub-Investigator: Grace Raja, MD         
Sub-Investigator: Thomas Sneed, MD         
Sub-Investigator: Diane Wilder, MD         
United States, California
City of Hope (City of Hope National Medical Center, City of Hope Medical Center) Recruiting
Duarte, California, United States, 91010
Contact: Kim A Margolin, MD    626-256-4673    kmargolin@coh.org   
Principal Investigator: Kim A Margolin, MD         
Sub-Investigator: Arya Amini, MD         
Sub-Investigator: Ammar A Chaudhry, MD         
Sub-Investigator: Savita Dandapani, MD, PhD         
Sub-Investigator: Tanya B Dorff, MD         
Sub-Investigator: Morganna Freeman, DO, FACP         
Sub-Investigator: Erminia Massarelli, MD, PhD, MS         
Sub-Investigator: Maria L Parayno, MD         
Sub-Investigator: Sagus Sampath, MD         
Sub-Investigator: Jeffrey YC Wong, MD, FASTRO         
Sub-Investigator: Dave M Yamauchi, MD         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Michael Graham, MD, PhD    319-356-4302    michael-graham@uiowa.edu   
Principal Investigator: Michael Graham, MD, PhD         
Sub-Investigator: Yusuf Menda, MD         
Sub-Investigator: Janet Pollard, MD         
Sub-Investigator: Parren McNeely, MD         
Sub-Investigator: David Bushnell, MD         
Sub-Investigator: Jiefu Zheng, MD         
Sub-Investigator: Mohammed Milhem, MD         
Sub-Investigator: Yousef Zakharia, MD         
Sub-Investigator: Rohan Garje, MD         
Sub-Investigator: Douglas Laux, MD         
Sub-Investigator: Sandeep Laroia, MD         
Sub-Investigator: Brendan O'Shea, MD         
Sub-Investigator: Mohammad Amarneh, MD         
United States, Massachusetts
Dana-Farber Cancer Institute (DFCI) Recruiting
Boston, Massachusetts, United States, 02215
Contact: Annick D Van den Abbeele, MD    617-632-3580    abbeele@dfci.harvard.edu   
Principal Investigator: Annick D Van den Abbeele, MD         
Sub-Investigator: Heather Jacene, MD         
Sub-Investigator: Stephen F Hodi, MD         
Sub-Investigator: Patrick Ott, MD, PhD         
Sub-Investigator: Rizwan Haq, MD, PhD         
Sub-Investigator: Elizabeth Buchbinder, MD         
Sub-Investigator: Benjamin Izar, MD, PhD         
Sub-Investigator: Megan Insco, MD, Phd         
Sub-Investigator: David Liu, MD, MPH         
Sub-Investigator: Jill Gormley, RN         
Sub-Investigator: Tera Feldman, PA-C         
Sub-Investigator: Meredith Davis, PA-C         
Sub-Investigator: Amanda Livengood, RN         
Sub-Investigator: Maria Gargano, PA-C         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Anthony Shields, PhD, MD    313-576-8735    shieldsa@karmanos.org   
Principal Investigator: Anthony Shields, PhD, MD         
Sub-Investigator: Lawrence Flaherty, MD         
Sub-Investigator: Elisabeth Heath, MD         
Sub-Investigator: Hirva Mamdani, MD         
Sub-Investigator: Misako Nagasaka, MD         
Sub-Investigator: Ammar Sukari, MD         
Sub-Investigator: Ulka Vaishampayan, MD         
Sub-Investigator: Amy Weise, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Barry A Siegel, MD    314-747-7222    siegelb@wustl.edu   
Principal Investigator: Barry A Siegal, MD         
Sub-Investigator: George Ansstas, MD         
Sub-Investigator: Douglas Adkins, MD         
Sub-Investigator: Daniel Morgansztern, MD         
Sub-Investigator: Farrokh Dehdashti, MD         
Sub-Investigator: Russell Pachynski, MD         
Sub-Investigator: Jennifer Frye, CNMT, CCRC         
Sub-Investigator: Helen Kaemmerer, CCRC         
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Contact: Michael Andrew Postow, MD    646-888-4589    Postowm@mskcc.org   
Principal Investigator: Michael Andrew Postow, MD         
Sub-Investigator: Jedd Wolchok, MD, PhD         
Sub-Investigator: Paul Chapman, MD         
Sub-Investigator: Margaret Callahan, MD, PhD         
Sub-Investigator: Alexander Shoushtari, MD         
United States, Oregon
Oregon Health& Science University (OHSU) Recruiting
Portland, Oregon, United States, 97239
Contact: Erik Mittra, MD, PhD    503-418-0990    mittra@ohsu.edu   
Principal Investigator: Erik Mittra, MD, PhD         
United States, Pennsylvania
University of Pennsylvania, Perelman School of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Michael Farwell, MD    215-662-7750    michael.farwell@uphs.upenn.edu   
Principal Investigator: Michael Farwell, MD         
Sub-Investigator: Dan Pryma, MD         
Sub-Investigator: Austin Pantel, MD         
Sub-Investigator: Charu Aggarwal, MD         
Sponsors and Collaborators
ImaginAb, Inc.
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Responsible Party: ImaginAb, Inc.
ClinicalTrials.gov Identifier: NCT03802123    
Other Study ID Numbers: IAB-CD8-201
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: December 2019
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
Keywords provided by ImaginAb, Inc.:
PET/CT
⁸⁹Zr-Df-IAB22M2C
CD8
Imaging