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

A Phase II, Open Label, Multi-Dose Study of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for Positron Emission Tomography (PET/CT) in Patients With Selected Advanced or Metastatic Solid Malignancies Who Are Scheduled to Receive Standard-of-Care Immunotherapy Only, As Single Agent or in Combination

The purpose of this study is to evaluate the safety of repeat doses ⁸⁹Zr-Df-IAB22M2C and to establish the relationship between ⁸⁹Zr-Df-IAB22M2C PET/CT lesion uptake with CD8+ cells by immunohistochemical staining in patients with selected advanced and metastatic solid malignancies who are scheduled to receive standard of care immunotherapy. The study will also evaluate uptake of ⁸⁹Zr-Df-IAB22M2C by PET/CT in patients at baseline and on immunotherapy.

Study Overview

• Status: Completed
• Conditions: Metastatic Solid Tumors; Positron-Emission Tomography
• Intervention / Treatment: Drug: ⁸⁹Zr-Df-IAB22M2C

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Up to 1 week prior to initiation of immunotherapy, patients will receive an injection of ⁸⁹Zr-Df-IAB22M2C (1.0 mCi) and will undergo PET/CT scanning to determine baseline uptake of ⁸⁹Zr-Df-IAB22M2C in tumor lesions and reference tissues. Patients will receive an additional injection of ⁸⁹Zr-Df-IAB22M2C (1.0 mCi) and PET/CT scan 4-6 weeks after starting immunotherapy (on-therapy) to evaluate uptake of ⁸⁹Zr-Df-IAB22M2C in tumor lesions and reference tissues, and to assess potential changes in uptake of ⁸⁹Zr-Df-IAB22M2C compared to the baseline scan.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama-Birmingham Hospital
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • CARTI Cancer Center
  • California
    • Duarte, California, United States, 91010
      • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
    • Los Angeles, California, United States, 90033
      • USC/Norris Comprehensive Cancer Center
    • Los Angeles, California, United States, 90033
      • Keck Hospital of USC
    • Los Angeles, California, United States, 90033
      • LAC + USC Medical Center
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian
    • Santa Monica, California, United States, 90404
      • John Wayne Cancer Institute at Providence Saint John's Health Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute (DFCI)
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania, Perelman School of Medicine
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance/ University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of ⁸⁹Zr-Df-IAB22M2C Uptake in Biopsied Tumors With CD8+ Cell Measurement by Immunohistochemistry (IHC)	Analyze ⁸⁹Zr-Df-IAB22M2C uptake in biopsied tumors as determined by SUV-based quantitative measures (SUVmax, SUVpeak, SUVmean, CD8 tumor volume, and tumor:reference tissue ratio) with CD8+ cell measurement determined by IHC from biopsy samples.	Baseline to 4-5 weeks after the start of immunotherapy
Number of Participants With Adverse Events	Number of participants who experienced any treatment emergent adverse events	Up to 12 weeks
Participants With Signs and Symptoms of Infusion Reactions	Number of participants with reported signs or symptoms of infusion reactions	Up to 12 weeks
Change in WBC Absolute Counts	WBC absolute counts	Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in Hematocrit (%) Laboratory Values	hematocrit (%) laboratory values	Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline	hemoglobin (g/dL) laboratory values compared with baseline results.	Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in Platelet Count Laboratory Values Compared With Baseline	platelet count laboratory values compared with baseline results.	Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in WBC Count Laboratory Values Compared With Baseline	WBC count laboratory values compared with baseline results.	Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in RBC Count Laboratory Values Compared With Baseline	RBC count laboratory values compared with baseline results.	Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline	blood glucose (mg/dL) laboratory values compared with baseline results.	Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in Chloride Laboratory Values Compared With Baseline	chloride laboratory values compared with baseline results.	Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in Potassium Laboratory Values Compared With Baseline	Potassium laboratory values compared with baseline results.	Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in Sodium Laboratory Values Compared With Baseline	sodium laboratory values compared with baseline results.	Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline	serum creatinine (mg/dL) laboratory values compared with baseline results.	Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in GGT (U/L) Laboratory Values Compared With Baseline	GGT (U/L) laboratory values compared with baseline results.	Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in BUN (mg/dL) Laboratory Values Compared With Baseline	BUN (mg/dL) laboratory values compared with baseline results.	Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Changes in LDH (U/L) Laboratory Values Comapared With Baseline	LDH (U/L) laboratory values compared with baseline results.	Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
Total Bilirubin (mg/dL) Laboratory Values	Total bilirubin (mg/dL) laboratory values compared with baseline results.	Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
ALP Laboratory Values	Change/shifts in ALP (U/L) laboratory values compared with baseline results.	Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
ALT Laboratory Values	Change/shifts in ALT (U/L) laboratory values compared with baseline results.	Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
AST Laboratory Values	Change/shifts in AST (U/L) laboratory values compared with baseline results.	Baseline, Visit 3 (Day 2), Visit 5 (Day 30-51) , Visit 6 (Day 31-52), Visit 7 (Day 30-65) and visit 8 (Day 58-86)
PR Interval Assessed by 12-Lead Electrocardiogram	PR interval reported in milliseconds (msecs)	Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)
Diastolic Blood Pressure	Diastolic Blood Pressure	Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
Evaluation of Heart Rate (Beats Per Minute)	Changes/shifts in heart rate	Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
Evaluation of Respiration Rate	Changes/shifts in respiration rate	Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
Evaluation of Temperature	Changes/shifts in temperature	Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
QRS Interval Assessed by 12-Lead Electrocardiogram	QRS Interval reported in milliseconds (msec)	Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)
QT Interval Assessed by 12-Lead Electrocardiogram	QT interval reported in milliseconds (msec)	Baseline, Visit 2 (Day1), Visit 5 (Day 30-51)
QTc Interval Assessed by 12-Lead Electrocardiogram	QTc interval reported in milliseconds (msecs)	Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Baseline and On-treatment ⁸⁹Zr-Df-IAB22M2C Uptake and Distribution in Lymphoid Organs, and Measurement of Change Between the Paired Observations	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: -SUVs in reference tissues	5 weeks
Measurement of Change in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) Uptake in Biopsied Tumors as Determined by SUV-based Quantitative Analysis	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)	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.	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.	7 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Assessment of changes in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) uptake and distribution from baseline to 5-7 days start of immunotherapy if available.	7 weeks
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.	Correlation of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) uptake with clinical outcomes	18 months

Collaborators and Investigators

• Sponsor: ImaginAb, Inc.
• Investigators: Study Director: Ron Korn, MD, PhD, ImaginAb, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2018
• Primary Completion (Actual): October 19, 2021
• Study Completion (Actual): July 18, 2022

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: January 9, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Imaging; PET/CT; CD8; ⁸⁹Zr-Df-IAB22M2C
• Other Study ID Numbers: IAB-CD8-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No