| 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. | Total number of patients with at least one evaluable biopsy sample and corresponding Zr-89 Df-AIB22M2C PET/CT scan | Posted | | Number | 95% Confidence Interval | r | | Baseline to 4-5 weeks after the start of immunotherapy | | | | ID | Title | Description |
|---|
| OG000 | 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) | | OG001 | Renal Cell Carcinoma Subgroup | Subgroup of all participants enrolled with a diagnosis of Renal Cell Carcinoma who have at least one evaluable biopsy and corresponding 89Zr Df-IAB22M2C PET/CT scan |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.3902(0.1479 to 0.5751)
- OG0010.7848(0.5988 to 0.8650)
|
|
| |
| Primary | Number of Participants With Adverse Events | Number of participants who experienced any treatment emergent adverse events | | Posted | | Count of Participants | | Participants | | Up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| | |
| Primary | Participants With Signs and Symptoms of Infusion Reactions | Number of participants with reported signs or symptoms of infusion reactions | | Posted | | Count of Participants | | Participants | | Up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | Change in WBC Absolute Counts | | 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. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | Changes in Hematocrit (%) Laboratory Values | hematocrit (%) laboratory values | 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. | Posted | | Mean | Standard Deviation | % by volume of red cells | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline | hemoglobin (g/dL) laboratory values compared with baseline results. | For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition. | Posted | | Mean | Standard Deviation | g/dl | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | Changes in Platelet Count Laboratory Values Compared With Baseline | platelet count laboratory values compared with baseline results. | 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. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | Changes in WBC Count Laboratory Values Compared With Baseline | WBC count laboratory values compared with baseline results. | 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. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | Changes in RBC Count Laboratory Values Compared With Baseline | RBC count laboratory values compared with baseline results. | 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. | Posted | | Mean | Standard Deviation | 10^12 cells/L | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline | blood glucose (mg/dL) laboratory values compared with baseline results. | 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. | Posted | | Mean | Standard Deviation | mg/dL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | Changes in Chloride Laboratory Values Compared With Baseline | chloride laboratory values compared with baseline results. | For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition. | Posted | | Mean | Standard Deviation | mEq/L | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | Changes in Potassium Laboratory Values Compared With Baseline | Potassium laboratory values compared with baseline results. | 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. | Posted | | Mean | Standard Deviation | mEQ/L | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | Changes in Sodium Laboratory Values Compared With Baseline | sodium laboratory values compared with baseline results. | 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. | Posted | | Mean | Standard Deviation | mEq/L | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline | serum creatinine (mg/dL) laboratory values compared with baseline results. | 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. | Posted | | Mean | Standard Deviation | mg/dL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | Changes in GGT (U/L) Laboratory Values Compared With Baseline | GGT (U/L) laboratory values compared with baseline results. | 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. | Posted | | Mean | Standard Deviation | U/L | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | Changes in BUN (mg/dL) Laboratory Values Compared With Baseline | BUN (mg/dL) laboratory values compared with baseline results. | 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. | Posted | | Mean | Standard Deviation | mg/dL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | Changes in LDH (U/L) Laboratory Values Comapared With Baseline | LDH (U/L) laboratory values compared with baseline results. | 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. | Posted | | Mean | Standard Deviation | U/L | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | Total Bilirubin (mg/dL) Laboratory Values | Total bilirubin (mg/dL) laboratory values compared with baseline results. | 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. | Posted | | Mean | Standard Deviation | mg/dL | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | ALP Laboratory Values | Change/shifts in ALP (U/L) laboratory values compared with baseline results. | 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. | Posted | | Mean | Standard Deviation | U/L | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | ALT Laboratory Values | Change/shifts in ALT (U/L) laboratory values compared with baseline results. | 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. | Posted | | Mean | Standard Deviation | U/L | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | AST Laboratory Values | Change/shifts in AST (U/L) laboratory values compared with baseline results. | 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. | Posted | | Mean | Standard Deviation | U/L | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | PR Interval Assessed by 12-Lead Electrocardiogram | PR interval reported in milliseconds (msecs) | fewer patients at later visits due to attrition | Posted | | Mean | Standard Deviation | msec | | Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | Diastolic Blood Pressure | | Not all patients completed all timepoints. | Posted | | Mean | Standard Deviation | mmHg | | Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | Evaluation of Heart Rate (Beats Per Minute) | Changes/shifts in heart rate | Not all patients completed all timepoints. | Posted | | Mean | Standard Deviation | beats/min | | Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | Evaluation of Respiration Rate | Changes/shifts in respiration rate | Not all patients completed all timepoints. | Posted | | Mean | Standard Deviation | breaths/min | | Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | Evaluation of Temperature | Changes/shifts in temperature | Not all patients completed all timepoints. | Posted | | Mean | Standard Deviation | degrees Celsius | | Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51), Visit 8 (Day 58-86) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | QRS Interval Assessed by 12-Lead Electrocardiogram | QRS Interval reported in milliseconds (msec) | fewer patients at later visits due to attrition | Posted | | Mean | Standard Deviation | milliseconds | | Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51) | | | | ID | Title | Description |
|---|
| OG000 | 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) |
| |
| Primary | QT Interval Assessed by 12-Lead Electrocardiogram | QT interval reported in milliseconds (msec) | fewer patients at later visits due to attrition | Posted | | Mean | Standard Deviation | milliseconds | | Baseline, Visit 2 (Day1), Visit 5 (Day 30-51) | | | | ID | Title | Description |
|---|
| OG000 | ⁸⁹Zr-Df-IAB22M2C Infusion | A dose of 3 mCi (±20%) or 1mCi (±20%) 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) |
| |
| Primary | QTc Interval Assessed by 12-Lead Electrocardiogram | QTc interval reported in milliseconds (msecs) | fewer patients at later visits due to attrition | Posted | | Mean | Standard Deviation | milliseconds | | Baseline, Visit 2 (Day 1), Visit 5 (Day 30-51) | | | | ID | Title | Description |
|---|
| OG000 | ⁸⁹Zr-Df-IAB22M2C Infusion | A dose of 3 mCi (±20%) or 1mCi (±20%) 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) |
| |
| 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 | | Posted | | Mean | Full Range | SUVmean | | 5 weeks | | | | ID | Title | Description |
|---|
| OG000 | ⁸⁹Zr-Df-IAB22M2C Infusion | A dose of 3 mCi (±20%) or 1mCi (±20%) 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) |
| |
| 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) | 36 patients with evaluable PET-biopsy pairs at baseline 33 patients with evaluable PET-biopsy pairs at on treatment | Posted | | Mean | Standard Deviation | SUV | | 7 weeks | | | | ID | Title | Description |
|---|
| OG000 | ⁸⁹Zr-Df-IAB22M2C Infusion | A dose of 3 mCi (±20%) or 1mCi (±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) |
| |
| 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. | | Posted | | Number | | number of lesions with this pattern | | 7 weeks | lesions | lesions | | ID | Title | Description |
|---|
| OG000 | Lesions With Paired Values (i.e. Baseline and On-treatment Are Both Available) Are Included | Only lesions with paired values (i.e. CD8 PET/CT Baseline and On-treatment are both available) are included |
| |
| 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. | | Not Posted | | | | | | 7 weeks | | Participants | | | | |
| 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. | | Not Posted | | | | | | 7 weeks | | Participants | | | | |
| 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. | | Not Posted | | | | | | 7 weeks | | Participants | | | | |
| 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 | | Not Posted | | | | | | 18 months | | Participants | | | | |