Metastatic Solid Tumors, Positron-Emission Tomography
Conditions
Keywords
PET/CT, ⁸⁹Zr-Df-IAB22M2C, CD8, Imaging
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.
Interventions
DRUG⁸⁹Zr-Df-IAB22M2C
⁸⁹Zr-Df-IAB22M2C CD8 T cell tracer for Positron Emission Tomography (PET)
Sponsors
ImaginAb, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QTc Interval Assessed by 12-Lead Electrocardiogram | Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51) | QTc interval reported in milliseconds (msecs) |
| PR Interval Assessed by 12-Lead Electrocardiogram | Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51) | PR interval reported in milliseconds (msecs) |
| Diastolic Blood Pressure | Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86) | Diastolic Blood Pressure |
| Evaluation of Heart Rate (Beats Per Minute) | Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86) | Changes/shifts in heart rate |
| Evaluation of Respiration Rate | Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86) | Changes/shifts in respiration rate |
| Evaluation of Temperature | Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86) | Changes/shifts in temperature |
| QRS Interval Assessed by 12-Lead Electrocardiogram | Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51) | QRS Interval reported in milliseconds (msec) |
| QT Interval Assessed by 12-Lead Electrocardiogram | Baseline, Visit 2 (Day1), Visit 5 (Day 30-51) | QT interval reported in milliseconds (msec) |
| Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline | 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) | serum creatinine (mg/dL) laboratory values compared with baseline results. |
| Changes in GGT (U/L) Laboratory Values Compared With Baseline | 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) | GGT (U/L) laboratory values compared with baseline results. |
| Correlation of ⁸⁹Zr-Df-IAB22M2C Uptake in Biopsied Tumors With CD8+ Cell Measurement by Immunohistochemistry (IHC) | Baseline to 4-5 weeks after the start of immunotherapy | 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. |
| Number of Participants With Adverse Events | Up to 12 weeks | Number of participants who experienced any treatment emergent adverse events |
| Participants With Signs and Symptoms of Infusion Reactions | Up to 12 weeks | Number of participants with reported signs or symptoms of infusion reactions |
| Change in 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) | WBC absolute counts |
| Changes in 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) | hematocrit (%) laboratory values |
| Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline | 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) | hemoglobin (g/dL) laboratory values compared with baseline results. |
| Changes in Platelet Count Laboratory Values Compared With Baseline | 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) | platelet count laboratory values compared with baseline results. |
| Changes in WBC Count Laboratory Values Compared With Baseline | 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) | WBC count laboratory values compared with baseline results. |
| Changes in RBC Count Laboratory Values Compared With Baseline | 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) | RBC count laboratory values compared with baseline results. |
| Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline | 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) | blood glucose (mg/dL) laboratory values compared with baseline results. |
| Changes in Chloride Laboratory Values Compared With Baseline | 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) | chloride laboratory values compared with baseline results. |
| Changes in Potassium Laboratory Values Compared With Baseline | 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) | Potassium laboratory values compared with baseline results. |
| Changes in Sodium Laboratory Values Compared With Baseline | 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) | sodium laboratory values compared with baseline results. |
| Changes in BUN (mg/dL) Laboratory Values Compared With Baseline | 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) | BUN (mg/dL) laboratory values compared with baseline results. |
| Changes in LDH (U/L) Laboratory Values Comapared With Baseline | 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) | LDH (U/L) laboratory values compared with baseline results. |
| Total Bilirubin (mg/dL) 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) | Total bilirubin (mg/dL) laboratory values compared with baseline results. |
| ALP 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) | Change/shifts in ALP (U/L) laboratory values compared with baseline results. |
| ALT 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) | Change/shifts in ALT (U/L) laboratory values compared with baseline results. |
| AST 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) | Change/shifts in AST (U/L) laboratory values compared with baseline results. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Baseline and On-treatment ⁸⁹Zr-Df-IAB22M2C Uptake and Distribution in Lymphoid Organs, and Measurement of Change Between the Paired Observations | 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: -SUVs in reference tissues |
| Measurement of Change in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) Uptake in Biopsied Tumors as Determined by SUV-based Quantitative Analysis | 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) |
| 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| 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 | Assessment of changes in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) uptake and distribution from baseline to 5-7 days start of immunotherapy if available. |
| 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. | 18 months | Correlation of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) uptake with clinical outcomes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion A dose of 3 mCi (±20%) or 1 mCi (±20%) of ⁸⁹Zr-Df-IAB22M2C at 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.
⁸⁹Zr-Df-IAB22M2C: ⁸⁹Zr-Df-IAB22M2C CD8 T cell tracer for Positron Emission Tomography (PET) | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Subject moved to hospice care | 1 |
| Overall Study | technician error | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | ⁸⁹Zr-Df-IAB22M2C Infusion |
|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 10.58 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 44 Participants |
| Region of Enrollment United States | 52 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 52 |
| other Total, other adverse events | 40 / 52 |
| serious Total, serious adverse events | 11 / 52 |
Outcome results
Primary
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)
Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition. For Treatment Visit 6, not all sites handle radioactive labs. For Treatment Visit 7, only available for pts who attended for biopsy on-treatment For Treatment Visit 8, Fewer than 52 due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | ALP Laboratory Values | Baseline | 98.980 U/L | Standard Deviation 46.687 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | ALP Laboratory Values | Treatment Visit 3 | 111.000 U/L | Standard Deviation 57.716 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | ALP Laboratory Values | Treatment Visit 5 | 102.341 U/L | Standard Deviation 61.689 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | ALP Laboratory Values | Treatment Visit 6 | 123.400 U/L | Standard Deviation 111.932 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | ALP Laboratory Values | Treatment Visit 7 | 97.357 U/L | Standard Deviation 29.57 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | ALP Laboratory Values | Treatment Visit 8 | 114.163 U/L | Standard Deviation 112.28 |
Primary
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)
Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition. For Treatment Visit 6, not all sites handle radioactive labs. For Treatment Visit 7, only available for pts who attended for biopsy on-treatment For Treatment Visit 8, Fewer than 52 due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | ALT Laboratory Values | Baseline | 23.336 U/L | Standard Deviation 17.428 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | ALT Laboratory Values | Treatment Visit 3 | 25.615 U/L | Standard Deviation 14.414 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | ALT Laboratory Values | Treatment Visit 5 | 29.615 U/L | Standard Deviation 22.315 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | ALT Laboratory Values | Treatment Visit 6 | 37.700 U/L | Standard Deviation 31.077 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | ALT Laboratory Values | Treatment Visit 7 | 27.071 U/L | Standard Deviation 23.685 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | ALT Laboratory Values | Treatment Visit 8 | 31.628 U/L | Standard Deviation 34.59 |
Primary
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)
Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition. For Treatment Visit 6, not all sites handle radioactive labs. For Treatment Visit 7, only available for pts who attended for biopsy on-treatment For Treatment Visit 8, Fewer than 52 due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | AST Laboratory Values | Baseline | 25.740 U/L | Standard Deviation 14.54 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | AST Laboratory Values | Treatment Visit 3 | 32.769 U/L | Standard Deviation 22.654 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | AST Laboratory Values | Treatment Visit 5 | 31.932 U/L | Standard Deviation 24.413 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | AST Laboratory Values | Treatment Visit 6 | 50.700 U/L | Standard Deviation 46.114 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | AST Laboratory Values | Treatment Visit 7 | 23.143 U/L | Standard Deviation 12.703 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | AST Laboratory Values | Treatment Visit 8 | 36.116 U/L | Standard Deviation 35.116 |
Primary
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)
Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition. For Treatment Visit 6, not all sites handle radioactive labs. For Treatment Visit 7, only available for pts who attended for biopsy on-treatment For Treatment Visit 8, Fewer than 52 due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Change in WBC Absolute Counts | Baseline | 7.6 10^9 cells/L | Standard Deviation 3.37 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Change in WBC Absolute Counts | Treatment Visit 3 | 7.7 10^9 cells/L | Standard Deviation 3.96 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Change in WBC Absolute Counts | Treatment Visit 5 | 6.3 10^9 cells/L | Standard Deviation 2.89 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Change in WBC Absolute Counts | Treatment Visit 6 | 6.2 10^9 cells/L | Standard Deviation 1.67 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Change in WBC Absolute Counts | Treatment Visit 7 | 6.4 10^9 cells/L | Standard Deviation 3.07 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Change in WBC Absolute Counts | Treatment Visit 8 | 6.4 10^9 cells/L | Standard Deviation 2.39 |
Primary
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)
Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition. For Treatment Visit 6, not all sites handle radioactive labs. For Treatment Visit 7, only available for pts who attended for biopsy on-treatment For Treatment Visit 8, Fewer than 52 due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline | Baseline | 115.986 mg/dL | Standard Deviation 39.297 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline | Treatment Visit 3 | 119.114 mg/dL | Standard Deviation 39.447 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline | Treatment Visit 5 | 115.534 mg/dL | Standard Deviation 31.67 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline | Treatment Visit 6 | 295.466 mg/dL | Standard Deviation 580.168 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline | Treatment Visit 7 | 108.651 mg/dL | Standard Deviation 17.977 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline | Treatment Visit 8 | 113.208 mg/dL | Standard Deviation 26.3 |
Primary
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)
Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition. For Treatment Visit 6, not all sites handle radioactive labs. For Treatment Visit 7, only available for pts who attended for biopsy on-treatment For Treatment Visit 8, Fewer than 52 due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in BUN (mg/dL) Laboratory Values Compared With Baseline | Baseline | 16.720 mg/dL | Standard Deviation 7.6 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in BUN (mg/dL) Laboratory Values Compared With Baseline | Treatment Visit 3 | 15.417 mg/dL | Standard Deviation 5.452 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in BUN (mg/dL) Laboratory Values Compared With Baseline | Treatment Visit 5 | 17.140 mg/dL | Standard Deviation 6.947 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in BUN (mg/dL) Laboratory Values Compared With Baseline | Treatment Visit 6 | 17.778 mg/dL | Standard Deviation 7.259 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in BUN (mg/dL) Laboratory Values Compared With Baseline | Treatment Visit 7 | 13.353 mg/dL | Standard Deviation 5.219 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in BUN (mg/dL) Laboratory Values Compared With Baseline | Treatment Visit 8 | 17.119 mg/dL | Standard Deviation 9.868 |
Primary
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)
Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Chloride Laboratory Values Compared With Baseline | Baseline | 102.255 mEq/L | Standard Deviation 3.903 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Chloride Laboratory Values Compared With Baseline | Treatment Visit 3 | 102.769 mEq/L | Standard Deviation 3.811 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Chloride Laboratory Values Compared With Baseline | Treatment Visit 5 | 102.364 mEq/L | Standard Deviation 3.498 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Chloride Laboratory Values Compared With Baseline | Treatment Visit 6 | 103.900 mEq/L | Standard Deviation 1.524 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Chloride Laboratory Values Compared With Baseline | Treatment Visit 7 | 103.059 mEq/L | Standard Deviation 3.28 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Chloride Laboratory Values Compared With Baseline | Treatment Visit 8 | 102.419 mEq/L | Standard Deviation 2.905 |
Primary
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)
Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition. For Treatment Visit 6, not all sites handle radioactive labs. For Treatment Visit 7, only available for pts who attended for biopsy on-treatment For Treatment Visit 8, Fewer than 52 due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in GGT (U/L) Laboratory Values Compared With Baseline | Baseline | 36.957 U/L | Standard Deviation 36.921 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in GGT (U/L) Laboratory Values Compared With Baseline | Treatment Visit 3 | 60.500 U/L | Standard Deviation 80.845 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in GGT (U/L) Laboratory Values Compared With Baseline | Treatment Visit 5 | 56.333 U/L | Standard Deviation 79.741 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in GGT (U/L) Laboratory Values Compared With Baseline | Treatment Visit 6 | 77.700 U/L | Standard Deviation 118.963 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in GGT (U/L) Laboratory Values Compared With Baseline | Treatment Visit 7 | 17.333 U/L | Standard Deviation 9.504 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in GGT (U/L) Laboratory Values Compared With Baseline | Treatment Visit 8 | 88.200 U/L | Standard Deviation 188.341 |
Primary
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)
Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition. For Treatment Visit 6, not all sites handle radioactive labs. For Treatment Visit 7, only available for pts who attended for biopsy on-treatment For Treatment Visit 8, Fewer than 52 due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Hematocrit (%) Laboratory Values | Baseline | 38.2 % by volume of red cells | Standard Deviation 5.44 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Hematocrit (%) Laboratory Values | Treatment Visit 3 | 37.7 % by volume of red cells | Standard Deviation 6.28 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Hematocrit (%) Laboratory Values | Treatment Visit 5 | 37.2 % by volume of red cells | Standard Deviation 4.86 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Hematocrit (%) Laboratory Values | Treatment Visit 6 | 38.7 % by volume of red cells | Standard Deviation 5.54 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Hematocrit (%) Laboratory Values | Treatment Visit 7 | 36.6 % by volume of red cells | Standard Deviation 6 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Hematocrit (%) Laboratory Values | Treatment Visit 8 | 36.5 % by volume of red cells | Standard Deviation 5.87 |
Primary
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)
Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline | Baseline | 12.5 g/dl | Standard Deviation 2.52 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline | Treatment Visit 3 | 12.4 g/dl | Standard Deviation 2.38 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline | Treatment Visit 5 | 12.1 g/dl | Standard Deviation 2.44 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline | Treatment Visit 6 | 12.8 g/dl | Standard Deviation 2.07 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline | Treatment Visit 7 | 12.1 g/dl | Standard Deviation 2.14 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline | Treatment Visit 8 | 12.1 g/dl | Standard Deviation 2.06 |
Primary
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)
Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition. For Treatment Visit 6, not all sites handle radioactive labs. For Treatment Visit 7, only available for pts who attended for biopsy on-treatment For Treatment Visit 8, Fewer than 52 due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in LDH (U/L) Laboratory Values Comapared With Baseline | Treatment Visit 3 | 281.000 U/L | Standard Deviation 149.534 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in LDH (U/L) Laboratory Values Comapared With Baseline | Baseline | 236.821 U/L | Standard Deviation 159.466 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in LDH (U/L) Laboratory Values Comapared With Baseline | Treatment Visit 5 | 310.375 U/L | Standard Deviation 383.334 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in LDH (U/L) Laboratory Values Comapared With Baseline | Treatment Visit 6 | 432.500 U/L | Standard Deviation 417.848 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in LDH (U/L) Laboratory Values Comapared With Baseline | Treatment Visit 7 | 271.000 U/L | Standard Deviation 133.907 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in LDH (U/L) Laboratory Values Comapared With Baseline | Treatment Visit 8 | 327.750 U/L | Standard Deviation 369.221 |
Primary
Changes in Platelet Count Laboratory Values Compared With Baseline
platelet 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)
Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition. For Treatment Visit 6, not all sites handle radioactive labs. For Treatment Visit 7, only available for pts who attended for biopsy on-treatment For Treatment Visit 8, Fewer than 52 due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Platelet Count Laboratory Values Compared With Baseline | Baseline | 270.1 10^9 cells/L | Standard Deviation 136.33 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Platelet Count Laboratory Values Compared With Baseline | Treatment Visit 3 | 224.5 10^9 cells/L | Standard Deviation 104.9 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Platelet Count Laboratory Values Compared With Baseline | Treatment Visit 5 | 227.2 10^9 cells/L | Standard Deviation 105.01 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Platelet Count Laboratory Values Compared With Baseline | Treatment Visit 6 | 227.0 10^9 cells/L | Standard Deviation 70.59 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Platelet Count Laboratory Values Compared With Baseline | Treatment Visit 7 | 249.7 10^9 cells/L | Standard Deviation 103.38 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Platelet Count Laboratory Values Compared With Baseline | Treatment Visit 8 | 242.1 10^9 cells/L | Standard Deviation 93.42 |
Primary
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)
Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition. For Treatment Visit 6, not all sites handle radioactive labs. For Treatment Visit 7, only available for pts who attended for biopsy on-treatment For Treatment Visit 8, Fewer than 52 due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Potassium Laboratory Values Compared With Baseline | Baseline | 4.314 mEQ/L | Standard Deviation 0.501 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Potassium Laboratory Values Compared With Baseline | Treatment Visit 3 | 4.038 mEQ/L | Standard Deviation 0.386 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Potassium Laboratory Values Compared With Baseline | Treatment Visit 5 | 4.223 mEQ/L | Standard Deviation 0.508 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Potassium Laboratory Values Compared With Baseline | Treatment Visit 6 | 4.080 mEQ/L | Standard Deviation 0.452 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Potassium Laboratory Values Compared With Baseline | Treatment Visit 7 | 4.333 mEQ/L | Standard Deviation 0.351 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Potassium Laboratory Values Compared With Baseline | Treatment Visit 8 | 4.233 mEQ/L | Standard Deviation 0.47 |
Primary
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)
Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition. For Treatment Visit 6, not all sites handle radioactive labs. For Treatment Visit 7, only available for pts who attended for biopsy on-treatment For Treatment Visit 8, Fewer than 52 due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in RBC Count Laboratory Values Compared With Baseline | Baseline | 4.3 10^12 cells/L | Standard Deviation 0.64 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in RBC Count Laboratory Values Compared With Baseline | Treatment Visit 3 | 4.1 10^12 cells/L | Standard Deviation 0.81 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in RBC Count Laboratory Values Compared With Baseline | Treatment Visit 5 | 4.2 10^12 cells/L | Standard Deviation 0.56 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in RBC Count Laboratory Values Compared With Baseline | Treatment Visit 6 | 4.3 10^12 cells/L | Standard Deviation 0.68 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in RBC Count Laboratory Values Compared With Baseline | Treatment Visit 7 | 4.1 10^12 cells/L | Standard Deviation 0.63 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in RBC Count Laboratory Values Compared With Baseline | Treatment Visit 8 | 4.1 10^12 cells/L | Standard Deviation 0.7 |
Primary
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)
Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition. For Treatment Visit 6, not all sites handle radioactive labs. For Treatment Visit 7, only available for pts who attended for biopsy on-treatment For Treatment Visit 8, Fewer than 52 due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline | Baseline | 0.930 mg/dL | Standard Deviation 0.289 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline | Treatment Visit 3 | 0.958 mg/dL | Standard Deviation 0.297 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline | Treatment Visit 5 | 0.934 mg/dL | Standard Deviation 0.332 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline | Treatment Visit 6 | 0.961 mg/dL | Standard Deviation 0.3 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline | Treatment Visit 7 | 0.834 mg/dL | Standard Deviation 0.28 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline | Treatment Visit 8 | 0.935 mg/dL | Standard Deviation 0.353 |
Primary
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)
Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition. For Treatment Visit 6, not all sites handle radioactive labs. For Treatment Visit 7, only available for pts who attended for biopsy on-treatment For Treatment Visit 8, Fewer than 52 due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Sodium Laboratory Values Compared With Baseline | Baseline | 137.510 mEq/L | Standard Deviation 3.19 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Sodium Laboratory Values Compared With Baseline | Treatment Visit 3 | 137.154 mEq/L | Standard Deviation 1.908 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Sodium Laboratory Values Compared With Baseline | Treatment Visit 5 | 137.227 mEq/L | Standard Deviation 2.868 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Sodium Laboratory Values Compared With Baseline | Treatment Visit 6 | 138.000 mEq/L | Standard Deviation 1.764 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Sodium Laboratory Values Compared With Baseline | Treatment Visit 7 | 137.556 mEq/L | Standard Deviation 2.854 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in Sodium Laboratory Values Compared With Baseline | Treatment Visit 8 | 137.326 mEq/L | Standard Deviation 2.286 |
Primary
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)
Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition. For Treatment Visit 6, not all sites handle radioactive labs. For Treatment Visit 7, only available for pts who attended for biopsy on-treatment For Treatment Visit 8, Fewer than 52 due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in WBC Count Laboratory Values Compared With Baseline | Baseline | 7.6 10^9 cells/L | Standard Deviation 3.37 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in WBC Count Laboratory Values Compared With Baseline | Treatment Visit 3 | 7.7 10^9 cells/L | Standard Deviation 3.96 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in WBC Count Laboratory Values Compared With Baseline | Treatment Visit 5 | 6.3 10^9 cells/L | Standard Deviation 2.89 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in WBC Count Laboratory Values Compared With Baseline | Treatment Visit 6 | 6.2 10^9 cells/L | Standard Deviation 1.67 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in WBC Count Laboratory Values Compared With Baseline | Treatment Visit 7 | 6.4 10^9 cells/L | Standard Deviation 3.07 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Changes in WBC Count Laboratory Values Compared With Baseline | Treatment Visit 8 | 6.4 10^9 cells/L | Standard Deviation 2.39 |
Primary
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
Population: Total number of patients with at least one evaluable biopsy sample and corresponding Zr-89 Df-AIB22M2C PET/CT scan
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Correlation of ⁸⁹Zr-Df-IAB22M2C Uptake in Biopsied Tumors With CD8+ Cell Measurement by Immunohistochemistry (IHC) | 0.3902 r |
| Renal Cell Carcinoma Subgroup | Correlation of ⁸⁹Zr-Df-IAB22M2C Uptake in Biopsied Tumors With CD8+ Cell Measurement by Immunohistochemistry (IHC) | 0.7848 r |
Primary
Diastolic Blood Pressure
Diastolic Blood Pressure
Time frame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
Population: Not all patients completed all timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Diastolic Blood Pressure | Baseline | 74.9 mmHg | Standard Deviation 8.94 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Diastolic Blood Pressure | Treatment Visit 2-Post Dose 1 Hour | 74.1 mmHg | Standard Deviation 8.92 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Diastolic Blood Pressure | Treatment Visit 5-Pre Dose | 75.3 mmHg | Standard Deviation 7.26 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Diastolic Blood Pressure | Treatment Visit 5-Post Dose 1 Hour | 74.9 mmHg | Standard Deviation 8.83 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Diastolic Blood Pressure | Treatment Visit 8 | 73.2 mmHg | Standard Deviation 8.65 |
Primary
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)
Population: Not all patients completed all timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Evaluation of Heart Rate (Beats Per Minute) | Baseline | 794 beats/min | Standard Deviation 12.3 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Evaluation of Heart Rate (Beats Per Minute) | Treatment Visit 2-Post Dose 1 Hour | 75.6 beats/min | Standard Deviation 11.99 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Evaluation of Heart Rate (Beats Per Minute) | Treatment Visit 5-Pre Dose | 78.7 beats/min | Standard Deviation 13.9 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Evaluation of Heart Rate (Beats Per Minute) | Treatment Visit 5-Post Dose 1 Hour | 76.5 beats/min | Standard Deviation 14.18 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Evaluation of Heart Rate (Beats Per Minute) | Treatment Visit 8 | 84.0 beats/min | Standard Deviation 17.49 |
Primary
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)
Population: Not all patients completed all timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Evaluation of Respiration Rate | Baseline | 16.8 breaths/min | Standard Deviation 2.78 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Evaluation of Respiration Rate | Treatment Visit 2-Post Dose 1 Hour | 17.2 breaths/min | Standard Deviation 3 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Evaluation of Respiration Rate | Treatment Visit 5-Pre Dose | 16.9 breaths/min | Standard Deviation 2.28 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Evaluation of Respiration Rate | Treatment Visit 5-Post dose 1 Hour | 16.7 breaths/min | Standard Deviation 1.72 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Evaluation of Respiration Rate | Treatment Visit 8 | 17.1 breaths/min | Standard Deviation 1.52 |
Primary
Evaluation of Temperature
Changes/shifts in temperature
Time frame: Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86)
Population: Not all patients completed all timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Evaluation of Temperature | Baseline | 36.7 degrees Celsius | Standard Deviation 0.3 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Evaluation of Temperature | Treatment Visit 2-Post Dose 1 Hour | 36.7 degrees Celsius | Standard Deviation 0.26 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Evaluation of Temperature | Treatment Visit 5-Pre Dose | 36.7 degrees Celsius | Standard Deviation 0.3 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Evaluation of Temperature | Treatment Visit 5-Post Dose 1 Hour | 36.7 degrees Celsius | Standard Deviation 0.29 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Evaluation of Temperature | Treatment Visit 8 | 36.6 degrees Celsius | Standard Deviation 0.41 |
Primary
Number of Participants With Adverse Events
Number of participants who experienced any treatment emergent adverse events
Time frame: Up to 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Number of Participants With Adverse Events | 40 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Participants With Signs and Symptoms of Infusion Reactions | 0 Participants |
Primary
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)
Population: fewer patients at later visits due to attrition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | PR Interval Assessed by 12-Lead Electrocardiogram | Baseline | 157.4 msec | Standard Deviation 30.97 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | PR Interval Assessed by 12-Lead Electrocardiogram | Treatment visit 2 - 1 Hour Post Dose | 159.1 msec | Standard Deviation 31.23 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | PR Interval Assessed by 12-Lead Electrocardiogram | Treatment Visit 5 - Pre Dose | 154.3 msec | Standard Deviation 25.55 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | PR Interval Assessed by 12-Lead Electrocardiogram | Treatment Visit 5-1 Hour Post Dose | 159.2 msec | Standard Deviation 28.86 |
Primary
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)
Population: fewer patients at later visits due to attrition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | QRS Interval Assessed by 12-Lead Electrocardiogram | Baseline | 89.7 milliseconds | Standard Deviation 15.84 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | QRS Interval Assessed by 12-Lead Electrocardiogram | Treatment Visit 2 | 90.4 milliseconds | Standard Deviation 18.17 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | QRS Interval Assessed by 12-Lead Electrocardiogram | Treatment Visit 5 Pre Dose | 89.9 milliseconds | Standard Deviation 16.47 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | QRS Interval Assessed by 12-Lead Electrocardiogram | Treatment Visit 5 Post Dose | 90.5 milliseconds | Standard Deviation 17.26 |
Primary
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)
Population: fewer patients at later visits due to attrition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | QTc Interval Assessed by 12-Lead Electrocardiogram | Baseline | 428.8 milliseconds | Standard Deviation 24.92 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | QTc Interval Assessed by 12-Lead Electrocardiogram | Treatment Visit 2 | 431.5 milliseconds | Standard Deviation 24.49 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | QTc Interval Assessed by 12-Lead Electrocardiogram | Treatment Visit 5 Pre Dose | 430.3 milliseconds | Standard Deviation 21.1 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | QTc Interval Assessed by 12-Lead Electrocardiogram | Treatment Visit 5 Post Dose | 430.3 milliseconds | Standard Deviation 21.1 |
Primary
QT Interval Assessed by 12-Lead Electrocardiogram
QT interval reported in milliseconds (msec)
Time frame: Baseline, Visit 2 (Day1), Visit 5 (Day 30-51)
Population: fewer patients at later visits due to attrition
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | QT Interval Assessed by 12-Lead Electrocardiogram | Baseline | 387.6 milliseconds | Standard Deviation 37.2 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | QT Interval Assessed by 12-Lead Electrocardiogram | Treatment Visit 2 | 394.0 milliseconds | Standard Deviation 38.49 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | QT Interval Assessed by 12-Lead Electrocardiogram | Treatment Visit 5 Pre Dose | 386.3 milliseconds | Standard Deviation 39.87 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | QT Interval Assessed by 12-Lead Electrocardiogram | Treatment Visit 5 Post Dose | 398.3 milliseconds | Standard Deviation 41.02 |
Primary
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)
Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition. For Treatment Visit 6, not all sites handle radioactive labs. For Treatment Visit 7, only available for pts who attended for biopsy on-treatment For Treatment Visit 8, Fewer than 52 due to attrition.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Total Bilirubin (mg/dL) Laboratory Values | Baseline | 0.497 mg/dL | Standard Deviation 0.279 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Total Bilirubin (mg/dL) Laboratory Values | Treatment Visit 3 | 0.562 mg/dL | Standard Deviation 0.195 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Total Bilirubin (mg/dL) Laboratory Values | Treatment Visit 5 | 0.553 mg/dL | Standard Deviation 0.325 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Total Bilirubin (mg/dL) Laboratory Values | Treatment Visit 6 | 0.511 mg/dL | Standard Deviation 0.272 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Total Bilirubin (mg/dL) Laboratory Values | Treatment Visit 7 | 0.559 mg/dL | Standard Deviation 0.341 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Total Bilirubin (mg/dL) Laboratory Values | Treatment Visit 8 | 0.545 mg/dL | Standard Deviation 0.306 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Assessment of Baseline and On-treatment ⁸⁹Zr-Df-IAB22M2C Uptake and Distribution in Lymphoid Organs, and Measurement of Change Between the Paired Observations | Spleen baseline | 63.5 SUVmean |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Assessment of Baseline and On-treatment ⁸⁹Zr-Df-IAB22M2C Uptake and Distribution in Lymphoid Organs, and Measurement of Change Between the Paired Observations | Spleen on treatment | 58.7 SUVmean |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Assessment of Baseline and On-treatment ⁸⁹Zr-Df-IAB22M2C Uptake and Distribution in Lymphoid Organs, and Measurement of Change Between the Paired Observations | bone marrow baseline | 7.6 SUVmean |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Assessment of Baseline and On-treatment ⁸⁹Zr-Df-IAB22M2C Uptake and Distribution in Lymphoid Organs, and Measurement of Change Between the Paired Observations | bone marrow on treatment | 7.4 SUVmean |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | 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. | Homogeneous - Heterogeneous or Mixed | 3 number of lesions with this pattern |
| ⁸⁹Zr-Df-IAB22M2C Infusion | 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. | Heterogeneous or Mixed -Heterogeneous or Mixed | 34 number of lesions with this pattern |
| ⁸⁹Zr-Df-IAB22M2C Infusion | 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. | Heterogeneous or Mixed - Homogeneous | 6 number of lesions with this pattern |
| ⁸⁹Zr-Df-IAB22M2C Infusion | 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. | Homogeneous - Homogeneous | 16 number of lesions with this pattern |
| ⁸⁹Zr-Df-IAB22M2C Infusion | 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. | Peripheral - Heterogeneous or Mixed | 2 number of lesions with this pattern |
| ⁸⁹Zr-Df-IAB22M2C Infusion | 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. | Peripheral - Peripheral | 8 number of lesions with this pattern |
Secondary
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
Population: 36 patients with evaluable PET-biopsy pairs at baseline 33 patients with evaluable PET-biopsy pairs at on treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | Measurement of Change in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) Uptake in Biopsied Tumors as Determined by SUV-based Quantitative Analysis | SUVmean baseline | 3.1 SUV | Standard Deviation 3.2 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Measurement of Change in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) Uptake in Biopsied Tumors as Determined by SUV-based Quantitative Analysis | SUVmax baseline | 5.1 SUV | Standard Deviation 5.3 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Measurement of Change in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) Uptake in Biopsied Tumors as Determined by SUV-based Quantitative Analysis | SUVpeak baseline | 3.6 SUV | Standard Deviation 4.2 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Measurement of Change in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) Uptake in Biopsied Tumors as Determined by SUV-based Quantitative Analysis | SUVmean on treatment | 4.0 SUV | Standard Deviation 3.3 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Measurement of Change in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) Uptake in Biopsied Tumors as Determined by SUV-based Quantitative Analysis | SUVmax on treatment | 6.5 SUV | Standard Deviation 5 |
| ⁸⁹Zr-Df-IAB22M2C Infusion | Measurement of Change in ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) Uptake in Biopsied Tumors as Determined by SUV-based Quantitative Analysis | SUVpeak on treatment | 4.6 SUV | Standard Deviation 3.9 |
Other Pre-specified
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.
Time frame: 7 weeks
Other Pre-specified
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
Time frame: 18 months
Other Pre-specified
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.
Time frame: 7 weeks
Other Pre-specified
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.
Time frame: 7 weeks