Clinical trial NCT03802123: ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for PET/CT in Patients With Metastatic Solid Tumors
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 Selected Advanced or Metastatic Solid Malignancies Who Are Scheduled to Receive Standard-of-Care Immunotherapy Only, As Single Agent or in Combination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Positron-Emission Tomography
Metastatic Solid Tumors
Keywords: PET/CT
⁸⁹Zr-Df-IAB22M2C
CD8
Imaging
Lead sponsor: ImaginAb, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-14
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: Correlation of ⁸⁹Zr-Df-IAB22M2C Uptake in Biopsied Tumors With CD8+ Cell Measurement by Immunohistochemistry (IHC)
timeFrame: Baseline to 4-5 weeks after the start of immunotherapy
measure: Number of Participants With Adverse Events
timeFrame: Up to 12 weeks
measure: Participants With Signs and Symptoms of Infusion Reactions
timeFrame: Up to 12 weeks
measure: Change in WBC Absolute Counts
timeFrame: 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)
measure: Changes in Hematocrit (%) Laboratory Values
timeFrame: 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)
measure: Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline
timeFrame: 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)
measure: Changes in Platelet Count Laboratory Values Compared With Baseline
timeFrame: 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)
measure: Changes in WBC Count Laboratory Values Compared With Baseline
timeFrame: 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)
measure: Changes in RBC Count Laboratory Values Compared With Baseline
timeFrame: 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)
measure: Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline
timeFrame: 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)
measure: Changes in Chloride Laboratory Values Compared With Baseline
timeFrame: 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)
measure: Changes in Potassium Laboratory Values Compared With Baseline
timeFrame: 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)
measure: Changes in Sodium Laboratory Values Compared With Baseline
timeFrame: 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)
measure: Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline
timeFrame: 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)
measure: Changes in GGT (U/L) Laboratory Values Compared With Baseline
timeFrame: 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)
measure: Changes in BUN (mg/dL) Laboratory Values Compared With Baseline
timeFrame: 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)
measure: Changes in LDH (U/L) Laboratory Values Comapared With Baseline
timeFrame: 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)
measure: Total Bilirubin (mg/dL) Laboratory Values
timeFrame: 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)
measure: ALP Laboratory Values
timeFrame: 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)
measure: ALT Laboratory Values
timeFrame: 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)
measure: AST Laboratory Values
timeFrame: 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)
measure: PR Interval Assessed by 12-Lead Electrocardiogram
timeFrame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)
measure: Diastolic Blood Pressure
timeFrame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
measure: Evaluation of Heart Rate (Beats Per Minute)
timeFrame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
measure: Evaluation of Respiration Rate
timeFrame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
measure: Evaluation of Temperature
timeFrame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
measure: QRS Interval Assessed by 12-Lead Electrocardiogram
timeFrame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)
measure: QT Interval Assessed by 12-Lead Electrocardiogram
timeFrame: Baseline, Visit 2 (Day1), Visit 5 (Day 30-51)
measure: QTc Interval Assessed by 12-Lead Electrocardiogram
timeFrame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51)
Secondary outcomes:
measure: Assessment of Baseline and On-treatment ⁸⁹Zr-Df-IAB22M2C Uptake and Distribution in Lymphoid Organs, and Measurement of Change Between the Paired Observations
timeFrame: 5 weeks
measure: Measurement of Change in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) Uptake in Biopsied Tumors as Determined by SUV-based Quantitative Analysis
timeFrame: 7 weeks
measure: 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.
timeFrame: 7 weeks
Other outcomes:
measure: 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.
timeFrame: 7 weeks
measure: 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.
timeFrame: 7 weeks
measure: Assessment of Changes in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) Uptake and Distribution From Baseline to 5-7 Days Start of Immunotherapy if Available.
timeFrame: 7 weeks
measure: 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.
timeFrame: 18 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama-Birmingham Hospital
state: Alabama
city: Little Rock
country: United States
facility: CARTI Cancer Center
state: Arkansas
city: Duarte
country: United States
facility: City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: LAC + USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute at Providence Saint John's Health Center
state: California
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Boston
country: United States
facility: Dana-Farber Cancer Institute (DFCI)
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania, Perelman School of Medicine
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance/ University of Washington
state: Washington
Study officials:
affiliation: ImaginAb, Inc.
name: Ron Korn, MD, PhD
role: STUDY_DIRECTOR
References: