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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 : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
ImaginAb, Inc.

Brief Summary:
Protocol IAB-CD8-201 is a Phase II, Open Label, Multi-Dose Study of Positron Emission Tomography (PET/CT) with ⁸⁹Zr-Df-IAB22M2C (CD8 Tracer) in Patients with Metastatic Solid Tumors. 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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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 Metastatic Solid Tumors
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: ⁸⁹Zr-Df-IAB22M2C Infusion
A dose of 3 mCi (±20%) of ⁸⁹Zr-Df-IAB22M2C between 0.5mg to 1.5mg of API will be administered intravenously over 5-10 minutes, within one week prior to the onset of cancer treatment, and 4 to 5 weeks after start of cancer treatment.
Drug: ⁸⁹Zr-Df-IAB22M2C
A dose of 3 mCi (±20%) of ⁸⁹Zr-Df-IAB22M2C between 0.5mg to 1.5mg of API will be administered intravenously over 5-10 minutes, within one week prior to the onset of cancer treatment, and 4 to 5 weeks after start of cancer treatment.




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 0-2 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.



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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. Patients with metastatic solid tumors with at least one non-radiated lesion.
  2. At least 1 measurable lesion documented on CT/MRI (RECIST criteria 1.1) within 45 days prior to first ⁸⁹Zr-Df-IAB22M2C 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:

Participants will be eligible for enrollment in the study only if they meet NONE 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.

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         
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      
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 Y.C. 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, FACR, FICIS    617-632-3580      
Principal Investigator: Annick D Van den Abbeele, MD, FACR, FICIS         
Sub-Investigator: Heather Jacene, MD         
Sub-Investigator: F Stephen 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    Siegel@gwumc.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, PET, 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      
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     History of Changes
Other Study ID Numbers: IAB-CD8-201
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 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
Additional relevant MeSH terms:
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Neoplasms