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

ImaginAb, Inc.52 enrolled

Overview

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.

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Positron-Emission Tomography Metastatic Solid Tumors

Interventions

⁸⁹Zr-Df-IAB22M2CDRUG

⁸⁹Zr-Df-IAB22M2C CD8 T cell tracer for Positron Emission Tomography (PET)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

University of Alabama-Birmingham Hospital

Birmingham, Alabama, United States

CARTI Cancer Center

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: Up to 12 weeks

Participants With Signs and Symptoms of Infusion Reactions

Number of participants with reported signs or symptoms of infusion reactions

Time frame: Up to 12 weeks

Change in WBC Absolute Counts

WBC absolute counts

Time frame: 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

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, United States

Keck Hospital of USC

Los Angeles, California, United States

LAC + USC Medical Center

Los Angeles, California, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

John Wayne Cancer Institute at Providence Saint John's Health Center

Santa Monica, California, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Dana-Farber Cancer Institute (DFCI)

Boston, Massachusetts, United States

...and 5 more locations

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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)

Time frame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)

Diastolic Blood Pressure

Time frame: 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

Time frame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)

Evaluation of Respiration Rate

Changes/shifts in respiration rate

Time frame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)

Evaluation of Temperature

Changes/shifts in temperature

Time frame: 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)

Time frame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)

QT Interval Assessed by 12-Lead Electrocardiogram

QT interval reported in milliseconds (msec)

Time frame: Baseline, Visit 2 (Day1), Visit 5 (Day 30-51)

QTc Interval Assessed by 12-Lead Electrocardiogram

QTc interval reported in milliseconds (msecs)

Time frame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)

Secondary Outcomes

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

Time frame: 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)

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.

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