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

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

Study Description

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

Detailed Description:

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 (Response evaluation criteria in solid tumors) version 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 immunohistochemistry (IHC).

The investigational imaging agent to be administered in this study will be ⁸⁹Zr-Df-IAB22M2C with whole body PET/CT imaging acquired within 1 week prior to the onset of immunotherapy and 4-5 weeks after start of immunotherapy. Approximately 84 participants are planned to be enrolled in this clinical study.

Participants should expect to have Conventional CT Chest, Abdomen and Pelvis (including Neck for SCCHN subjects) or MRI or whole body 18-FDG-PET scan will be performed within 45 days prior to 1st infusion of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer); PET/CT scans at 24±3 hours after each infusion of ⁸⁹Zr-Df-IAB22M2C; and fresh tumor biopsy (1 to 3 core biopsies) will be performed at Baseline (-28 to -7 days prior to 1st infusion of ⁸⁹Zr-Df-IAB22M2C and within 2 weeks after 2nd infusion of ⁸⁹Zr-Df-IAB22M2C and its associated PET/CT scan. Archival tumor biopsy tissues obtained within 2 months prior to 1st infusion of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) may be submitted in place of Baseline fresh biopsy, with approval from the Sponsor.

In addition, anti-drug antibody (ADA) blood samples will be collected at the following time points: at Baseline, prior to receiving the 2nd infusion of ⁸⁹Zr-Df-IAB22M2C, and at End-of-Study safety follow-up visit.

At each study visit, participants will be questioned concerning any new medications or changes in current medications including over-the-counter and topical medications.

The safety monitoring practices employed by this protocol are adequate to protect the participants' safety and should detect all Treatment Emergent Adverse Events (TEAEs). The safety follow-up (4-6 weeks after the last dose of ⁸⁹Zr-Df-IAB22M2C) and the extended follow-up (up to 18 months after start of cancer treatment) to collect Standard of Care (SOC) imaging only were also established.

A participant who completes Visit 9 will be considered to have completed the study. All participants have the right to withdraw at their own request at any point during the study without prejudice. Although participants do not need to give a reason for requesting withdrawal from the trial, the Investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the participant's rights.

A Statistical Analysis Plan (SAP) will be developed and approved before the database is locked. The SAP will present the detailed statistical methodology to be used in analyzing the efficacy and tabulating the safety data from this trial. All inferential statistical analyses will be based on a two-sided test with a Type I error rate of 0.05. The primary analysis of the primary and secondary outcome measures will be conducted using the Per Protocol (PP) population. Analyses of safety outcomes will be conducted using the safety population. Adverse events will be coded using the most recent version of MedDRA. TEAEs will be summarized by treatment group and by stage in the study, System Organ Class, and preferred term. In addition, all the data from physical examination, 12 Lead Electrocardiogram (ECG) and vital signs will also be descriptively summarized. The final statistical analysis of data will be performed after all clinical monitoring has been completed, all data queries have been resolved, and all data have been verified (Quality Control checked) prior to formal database lock. The Sponsor will authorize the final database lock.

For quality control and quality assurance purpose, the Sponsor's designated monitor will visit the center(s) during the study as well as maintain frequent telephone and written communication to maintain current personal knowledge of the progress of a study. The Investigator will permit the Sponsor to monitor the study as frequently as is deemed necessary and provide access to medical records to ensure that data are being recorded adequately, that data are verifiable and that protocol adherence is satisfactory. The Investigator will permit representatives of the Sponsor and/or designated Contract Research Organization (CRO) to inspect all Case Report Forms (CRFs) and corresponding study participant original medical records (source documents) at regular intervals throughout the study. Site inspections serve to verify strict adherence to the protocol and the accuracy of the data being entered on the CRFs, in accordance with federal regulations. A Monitoring Log will be maintained at each study site that the monitor will sign, date, and state the type of visit.

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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.

More Information

• Responsible Party: ImaginAb, Inc.
• ClinicalTrials.gov Identifier: NCT03802123
• Other Study ID Numbers: IAB-CD8-201
• First Posted: January 14, 2019
• Last Update Posted: February 13, 2020
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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