Trial Outcomes & Findings for ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for PET/CT in Patients With Metastatic Solid Tumors (NCT NCT03802123)

NCT ID: NCT03802123

Last Updated: 2024-07-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 52 participants
• Primary outcome timeframe: Baseline to 4-5 weeks after the start of immunotherapy
• Results posted on: 2024-07-09

Participant Flow

Participant milestones

Measure	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)
Overall Study STARTED	52
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	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)
Overall Study Withdrawal by Subject	3
Overall Study Physician Decision	1
Overall Study Subject moved to hospice care	1
Overall Study technician error	1
Overall Study Death	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)
Age, Continuous	64.1 years STANDARD_DEVIATION 10.58 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=49 Participants 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)	Renal Cell Carcinoma Subgroup n=17 Participants 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
Correlation of ⁸⁹Zr-Df-IAB22M2C Uptake in Biopsied Tumors With CD8+ Cell Measurement by Immunohistochemistry (IHC)	0.3902 r Interval 0.1479 to 0.5751	0.7848 r Interval 0.5988 to 0.865

PRIMARY outcome

Timeframe: Up to 12 weeks

Number of participants who experienced any treatment emergent adverse events

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Number of Participants With Adverse Events	40 Participants	—

PRIMARY outcome

Timeframe: Up to 12 weeks

Number of participants with reported signs or symptoms of infusion reactions

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Participants With Signs and Symptoms of Infusion Reactions	0 Participants	—

PRIMARY outcome

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)

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.

WBC absolute counts

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Change in WBC Absolute Counts Baseline	7.6 10^9 cells/L Standard Deviation 3.37	—
Change in WBC Absolute Counts Treatment Visit 3	7.7 10^9 cells/L Standard Deviation 3.96	—
Change in WBC Absolute Counts Treatment Visit 5	6.3 10^9 cells/L Standard Deviation 2.89	—
Change in WBC Absolute Counts Treatment Visit 6	6.2 10^9 cells/L Standard Deviation 1.67	—
Change in WBC Absolute Counts Treatment Visit 7	6.4 10^9 cells/L Standard Deviation 3.07	—
Change in WBC Absolute Counts Treatment Visit 8	6.4 10^9 cells/L Standard Deviation 2.39	—

PRIMARY outcome

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)

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.

hematocrit (%) laboratory values

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Changes in Hematocrit (%) Laboratory Values Baseline	38.2 % by volume of red cells Standard Deviation 5.44	—
Changes in Hematocrit (%) Laboratory Values Treatment Visit 3	37.7 % by volume of red cells Standard Deviation 6.28	—
Changes in Hematocrit (%) Laboratory Values Treatment Visit 5	37.2 % by volume of red cells Standard Deviation 4.86	—
Changes in Hematocrit (%) Laboratory Values Treatment Visit 6	38.7 % by volume of red cells Standard Deviation 5.54	—
Changes in Hematocrit (%) Laboratory Values Treatment Visit 7	36.6 % by volume of red cells Standard Deviation 6.0	—
Changes in Hematocrit (%) Laboratory Values Treatment Visit 8	36.5 % by volume of red cells Standard Deviation 5.87	—

PRIMARY outcome

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)

Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition.

hemoglobin (g/dL) laboratory values compared with baseline results.

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline Baseline	12.5 g/dl Standard Deviation 2.52	—
Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline Treatment Visit 3	12.4 g/dl Standard Deviation 2.38	—
Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline Treatment Visit 5	12.1 g/dl Standard Deviation 2.44	—
Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline Treatment Visit 6	12.8 g/dl Standard Deviation 2.07	—
Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline Treatment Visit 7	12.1 g/dl Standard Deviation 2.14	—
Changes in Hemoglobin (g/dL) Laboratory Values Compared With Baseline Treatment Visit 8	12.1 g/dl Standard Deviation 2.06	—

PRIMARY outcome

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)

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.

platelet count laboratory values compared with baseline results.

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Changes in Platelet Count Laboratory Values Compared With Baseline Baseline	270.1 10^9 cells/L Standard Deviation 136.33	—
Changes in Platelet Count Laboratory Values Compared With Baseline Treatment Visit 3	224.5 10^9 cells/L Standard Deviation 104.90	—
Changes in Platelet Count Laboratory Values Compared With Baseline Treatment Visit 5	227.2 10^9 cells/L Standard Deviation 105.01	—
Changes in Platelet Count Laboratory Values Compared With Baseline Treatment Visit 6	227.0 10^9 cells/L Standard Deviation 70.59	—
Changes in Platelet Count Laboratory Values Compared With Baseline Treatment Visit 7	249.7 10^9 cells/L Standard Deviation 103.38	—
Changes in Platelet Count Laboratory Values Compared With Baseline Treatment Visit 8	242.1 10^9 cells/L Standard Deviation 93.42	—

PRIMARY outcome

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)

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.

WBC count laboratory values compared with baseline results.

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Changes in WBC Count Laboratory Values Compared With Baseline Baseline	7.6 10^9 cells/L Standard Deviation 3.37	—
Changes in WBC Count Laboratory Values Compared With Baseline Treatment Visit 3	7.7 10^9 cells/L Standard Deviation 3.96	—
Changes in WBC Count Laboratory Values Compared With Baseline Treatment Visit 5	6.3 10^9 cells/L Standard Deviation 2.89	—
Changes in WBC Count Laboratory Values Compared With Baseline Treatment Visit 6	6.2 10^9 cells/L Standard Deviation 1.67	—
Changes in WBC Count Laboratory Values Compared With Baseline Treatment Visit 7	6.4 10^9 cells/L Standard Deviation 3.07	—
Changes in WBC Count Laboratory Values Compared With Baseline Treatment Visit 8	6.4 10^9 cells/L Standard Deviation 2.39	—

PRIMARY outcome

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)

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.

RBC count laboratory values compared with baseline results.

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Changes in RBC Count Laboratory Values Compared With Baseline Baseline	4.3 10^12 cells/L Standard Deviation 0.64	—
Changes in RBC Count Laboratory Values Compared With Baseline Treatment Visit 3	4.1 10^12 cells/L Standard Deviation 0.81	—
Changes in RBC Count Laboratory Values Compared With Baseline Treatment Visit 5	4.2 10^12 cells/L Standard Deviation 0.56	—
Changes in RBC Count Laboratory Values Compared With Baseline Treatment Visit 6	4.3 10^12 cells/L Standard Deviation 0.68	—
Changes in RBC Count Laboratory Values Compared With Baseline Treatment Visit 7	4.1 10^12 cells/L Standard Deviation 0.63	—
Changes in RBC Count Laboratory Values Compared With Baseline Treatment Visit 8	4.1 10^12 cells/L Standard Deviation 0.70	—

PRIMARY outcome

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)

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.

blood glucose (mg/dL) laboratory values compared with baseline results.

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline Treatment Visit 6	295.466 mg/dL Standard Deviation 580.168	—
Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline Treatment Visit 7	108.651 mg/dL Standard Deviation 17.977	—
Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline Baseline	115.986 mg/dL Standard Deviation 39.297	—
Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline Treatment Visit 3	119.114 mg/dL Standard Deviation 39.447	—
Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline Treatment Visit 5	115.534 mg/dL Standard Deviation 31.670	—
Changes in Blood Glucose (mg/dL) Laboratory Values Compared With Baseline Treatment Visit 8	113.208 mg/dL Standard Deviation 26.300	—

PRIMARY outcome

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)

Population: For Treatment Visit 3, not all sites handle radioactive labs. For Treatment Visit 5, Fewer than 52 due to attrition.

chloride laboratory values compared with baseline results.

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Changes in Chloride Laboratory Values Compared With Baseline Baseline	102.255 mEq/L Standard Deviation 3.903	—
Changes in Chloride Laboratory Values Compared With Baseline Treatment Visit 3	102.769 mEq/L Standard Deviation 3.811	—
Changes in Chloride Laboratory Values Compared With Baseline Treatment Visit 5	102.364 mEq/L Standard Deviation 3.498	—
Changes in Chloride Laboratory Values Compared With Baseline Treatment Visit 6	103.900 mEq/L Standard Deviation 1.524	—
Changes in Chloride Laboratory Values Compared With Baseline Treatment Visit 7	103.059 mEq/L Standard Deviation 3.280	—
Changes in Chloride Laboratory Values Compared With Baseline Treatment Visit 8	102.419 mEq/L Standard Deviation 2.905	—

PRIMARY outcome

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)

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.

Potassium laboratory values compared with baseline results.

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Changes in Potassium Laboratory Values Compared With Baseline Baseline	4.314 mEQ/L Standard Deviation 0.501	—
Changes in Potassium Laboratory Values Compared With Baseline Treatment Visit 3	4.038 mEQ/L Standard Deviation 0.386	—
Changes in Potassium Laboratory Values Compared With Baseline Treatment Visit 5	4.223 mEQ/L Standard Deviation 0.508	—
Changes in Potassium Laboratory Values Compared With Baseline Treatment Visit 6	4.080 mEQ/L Standard Deviation 0.452	—
Changes in Potassium Laboratory Values Compared With Baseline Treatment Visit 7	4.333 mEQ/L Standard Deviation 0.351	—
Changes in Potassium Laboratory Values Compared With Baseline Treatment Visit 8	4.233 mEQ/L Standard Deviation 0.470	—

PRIMARY outcome

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)

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.

sodium laboratory values compared with baseline results.

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Changes in Sodium Laboratory Values Compared With Baseline Baseline	137.510 mEq/L Standard Deviation 3.190	—
Changes in Sodium Laboratory Values Compared With Baseline Treatment Visit 3	137.154 mEq/L Standard Deviation 1.908	—
Changes in Sodium Laboratory Values Compared With Baseline Treatment Visit 5	137.227 mEq/L Standard Deviation 2.868	—
Changes in Sodium Laboratory Values Compared With Baseline Treatment Visit 6	138.000 mEq/L Standard Deviation 1.764	—
Changes in Sodium Laboratory Values Compared With Baseline Treatment Visit 7	137.556 mEq/L Standard Deviation 2.854	—
Changes in Sodium Laboratory Values Compared With Baseline Treatment Visit 8	137.326 mEq/L Standard Deviation 2.286	—

PRIMARY outcome

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)

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.

serum creatinine (mg/dL) laboratory values compared with baseline results.

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline Baseline	0.930 mg/dL Standard Deviation 0.289	—
Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline Treatment Visit 3	0.958 mg/dL Standard Deviation 0.297	—
Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline Treatment Visit 5	0.934 mg/dL Standard Deviation 0.332	—
Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline Treatment Visit 6	0.961 mg/dL Standard Deviation 0.300	—
Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline Treatment Visit 7	0.834 mg/dL Standard Deviation 0.280	—
Changes in Serum Creatinine (mg/dL) Laboratory Values Compared With Baseline Treatment Visit 8	0.935 mg/dL Standard Deviation 0.353	—

PRIMARY outcome

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)

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.

GGT (U/L) laboratory values compared with baseline results.

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Changes in GGT (U/L) Laboratory Values Compared With Baseline Baseline	36.957 U/L Standard Deviation 36.921	—
Changes in GGT (U/L) Laboratory Values Compared With Baseline Treatment Visit 3	60.500 U/L Standard Deviation 80.845	—
Changes in GGT (U/L) Laboratory Values Compared With Baseline Treatment Visit 5	56.333 U/L Standard Deviation 79.741	—
Changes in GGT (U/L) Laboratory Values Compared With Baseline Treatment Visit 6	77.700 U/L Standard Deviation 118.963	—
Changes in GGT (U/L) Laboratory Values Compared With Baseline Treatment Visit 7	17.333 U/L Standard Deviation 9.504	—
Changes in GGT (U/L) Laboratory Values Compared With Baseline Treatment Visit 8	88.200 U/L Standard Deviation 188.341	—

PRIMARY outcome

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)

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.

BUN (mg/dL) laboratory values compared with baseline results.

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Changes in BUN (mg/dL) Laboratory Values Compared With Baseline Baseline	16.720 mg/dL Standard Deviation 7.600	—
Changes in BUN (mg/dL) Laboratory Values Compared With Baseline Treatment Visit 3	15.417 mg/dL Standard Deviation 5.452	—
Changes in BUN (mg/dL) Laboratory Values Compared With Baseline Treatment Visit 5	17.140 mg/dL Standard Deviation 6.947	—
Changes in BUN (mg/dL) Laboratory Values Compared With Baseline Treatment Visit 6	17.778 mg/dL Standard Deviation 7.259	—
Changes in BUN (mg/dL) Laboratory Values Compared With Baseline Treatment Visit 7	13.353 mg/dL Standard Deviation 5.219	—
Changes in BUN (mg/dL) Laboratory Values Compared With Baseline Treatment Visit 8	17.119 mg/dL Standard Deviation 9.868	—

PRIMARY outcome

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)

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.

LDH (U/L) laboratory values compared with baseline results.

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Changes in LDH (U/L) Laboratory Values Comapared With Baseline Baseline	236.821 U/L Standard Deviation 159.466	—
Changes in LDH (U/L) Laboratory Values Comapared With Baseline Treatment Visit 3	281.000 U/L Standard Deviation 149.534	—
Changes in LDH (U/L) Laboratory Values Comapared With Baseline Treatment Visit 5	310.375 U/L Standard Deviation 383.334	—
Changes in LDH (U/L) Laboratory Values Comapared With Baseline Treatment Visit 6	432.500 U/L Standard Deviation 417.848	—
Changes in LDH (U/L) Laboratory Values Comapared With Baseline Treatment Visit 7	271.000 U/L Standard Deviation 133.907	—
Changes in LDH (U/L) Laboratory Values Comapared With Baseline Treatment Visit 8	327.750 U/L Standard Deviation 369.221	—

PRIMARY outcome

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)

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.

Total bilirubin (mg/dL) laboratory values compared with baseline results.

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Total Bilirubin (mg/dL) Laboratory Values Baseline	0.497 mg/dL Standard Deviation 0.279	—
Total Bilirubin (mg/dL) Laboratory Values Treatment Visit 3	0.562 mg/dL Standard Deviation 0.195	—
Total Bilirubin (mg/dL) Laboratory Values Treatment Visit 5	0.553 mg/dL Standard Deviation 0.325	—
Total Bilirubin (mg/dL) Laboratory Values Treatment Visit 6	0.511 mg/dL Standard Deviation 0.272	—
Total Bilirubin (mg/dL) Laboratory Values Treatment Visit 7	0.559 mg/dL Standard Deviation 0.341	—
Total Bilirubin (mg/dL) Laboratory Values Treatment Visit 8	0.545 mg/dL Standard Deviation 0.306	—

PRIMARY outcome

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)

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.

Change/shifts in ALP (U/L) laboratory values compared with baseline results.

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
ALP Laboratory Values Baseline	98.980 U/L Standard Deviation 46.687	—
ALP Laboratory Values Treatment Visit 3	111.000 U/L Standard Deviation 57.716	—
ALP Laboratory Values Treatment Visit 5	102.341 U/L Standard Deviation 61.689	—
ALP Laboratory Values Treatment Visit 6	123.400 U/L Standard Deviation 111.932	—
ALP Laboratory Values Treatment Visit 7	97.357 U/L Standard Deviation 29.570	—
ALP Laboratory Values Treatment Visit 8	114.163 U/L Standard Deviation 112.280	—

PRIMARY outcome

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)

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.

Change/shifts in ALT (U/L) laboratory values compared with baseline results.

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
ALT Laboratory Values Baseline	23.336 U/L Standard Deviation 17.428	—
ALT Laboratory Values Treatment Visit 3	25.615 U/L Standard Deviation 14.414	—
ALT Laboratory Values Treatment Visit 5	29.615 U/L Standard Deviation 22.315	—
ALT Laboratory Values Treatment Visit 6	37.700 U/L Standard Deviation 31.077	—
ALT Laboratory Values Treatment Visit 7	27.071 U/L Standard Deviation 23.685	—
ALT Laboratory Values Treatment Visit 8	31.628 U/L Standard Deviation 34.590	—

PRIMARY outcome

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)

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.

Change/shifts in AST (U/L) laboratory values compared with baseline results.

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
AST Laboratory Values Baseline	25.740 U/L Standard Deviation 14.540	—
AST Laboratory Values Treatment Visit 3	32.769 U/L Standard Deviation 22.654	—
AST Laboratory Values Treatment Visit 5	31.932 U/L Standard Deviation 24.413	—
AST Laboratory Values Treatment Visit 6	50.700 U/L Standard Deviation 46.114	—
AST Laboratory Values Treatment Visit 7	23.143 U/L Standard Deviation 12.703	—
AST Laboratory Values Treatment Visit 8	36.116 U/L Standard Deviation 35.116	—

PRIMARY outcome

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

Population: fewer patients at later visits due to attrition

PR interval reported in milliseconds (msecs)

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
PR Interval Assessed by 12-Lead Electrocardiogram Baseline	157.4 msec Standard Deviation 30.97	—
PR Interval Assessed by 12-Lead Electrocardiogram Treatment visit 2 - 1 Hour Post Dose	159.1 msec Standard Deviation 31.23	—
PR Interval Assessed by 12-Lead Electrocardiogram Treatment Visit 5 - Pre Dose	154.3 msec Standard Deviation 25.55	—
PR Interval Assessed by 12-Lead Electrocardiogram Treatment Visit 5-1 Hour Post Dose	159.2 msec Standard Deviation 28.86	—

PRIMARY outcome

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

Population: Not all patients completed all timepoints.

Diastolic Blood Pressure

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Diastolic Blood Pressure Baseline	74.9 mmHg Standard Deviation 8.94	—
Diastolic Blood Pressure Treatment Visit 2-Post Dose 1 Hour	74.1 mmHg Standard Deviation 8.92	—
Diastolic Blood Pressure Treatment Visit 5-Pre Dose	75.3 mmHg Standard Deviation 7.26	—
Diastolic Blood Pressure Treatment Visit 5-Post Dose 1 Hour	74.9 mmHg Standard Deviation 8.83	—
Diastolic Blood Pressure Treatment Visit 8	73.2 mmHg Standard Deviation 8.65	—

PRIMARY outcome

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

Population: Not all patients completed all timepoints.

Changes/shifts in heart rate

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Evaluation of Heart Rate (Beats Per Minute) Baseline	794 beats/min Standard Deviation 12.30	—
Evaluation of Heart Rate (Beats Per Minute) Treatment Visit 2-Post Dose 1 Hour	75.6 beats/min Standard Deviation 11.99	—
Evaluation of Heart Rate (Beats Per Minute) Treatment Visit 5-Pre Dose	78.7 beats/min Standard Deviation 13.90	—
Evaluation of Heart Rate (Beats Per Minute) Treatment Visit 5-Post Dose 1 Hour	76.5 beats/min Standard Deviation 14.18	—
Evaluation of Heart Rate (Beats Per Minute) Treatment Visit 8	84.0 beats/min Standard Deviation 17.49	—

PRIMARY outcome

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

Population: Not all patients completed all timepoints.

Changes/shifts in respiration rate

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Evaluation of Respiration Rate Treatment Visit 8	17.1 breaths/min Standard Deviation 1.52	—
Evaluation of Respiration Rate Baseline	16.8 breaths/min Standard Deviation 2.78	—
Evaluation of Respiration Rate Treatment Visit 2-Post Dose 1 Hour	17.2 breaths/min Standard Deviation 3.00	—
Evaluation of Respiration Rate Treatment Visit 5-Pre Dose	16.9 breaths/min Standard Deviation 2.28	—
Evaluation of Respiration Rate Treatment Visit 5-Post dose 1 Hour	16.7 breaths/min Standard Deviation 1.72	—

PRIMARY outcome

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

Population: Not all patients completed all timepoints.

Changes/shifts in temperature

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
Evaluation of Temperature Baseline	36.7 degrees Celsius Standard Deviation 0.30	—
Evaluation of Temperature Treatment Visit 2-Post Dose 1 Hour	36.7 degrees Celsius Standard Deviation 0.26	—
Evaluation of Temperature Treatment Visit 5-Pre Dose	36.7 degrees Celsius Standard Deviation 0.30	—
Evaluation of Temperature Treatment Visit 5-Post Dose 1 Hour	36.7 degrees Celsius Standard Deviation 0.29	—
Evaluation of Temperature Treatment Visit 8	36.6 degrees Celsius Standard Deviation 0.41	—

PRIMARY outcome

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

Population: fewer patients at later visits due to attrition

QRS Interval reported in milliseconds (msec)

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
QRS Interval Assessed by 12-Lead Electrocardiogram Baseline	89.7 milliseconds Standard Deviation 15.84	—
QRS Interval Assessed by 12-Lead Electrocardiogram Treatment Visit 2	90.4 milliseconds Standard Deviation 18.17	—
QRS Interval Assessed by 12-Lead Electrocardiogram Treatment Visit 5 Pre Dose	89.9 milliseconds Standard Deviation 16.47	—
QRS Interval Assessed by 12-Lead Electrocardiogram Treatment Visit 5 Post Dose	90.5 milliseconds Standard Deviation 17.26	—

PRIMARY outcome

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

Population: fewer patients at later visits due to attrition

QT interval reported in milliseconds (msec)

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
QT Interval Assessed by 12-Lead Electrocardiogram Baseline	387.6 milliseconds Standard Deviation 37.20	—
QT Interval Assessed by 12-Lead Electrocardiogram Treatment Visit 2	394.0 milliseconds Standard Deviation 38.49	—
QT Interval Assessed by 12-Lead Electrocardiogram Treatment Visit 5 Pre Dose	386.3 milliseconds Standard Deviation 39.87	—
QT Interval Assessed by 12-Lead Electrocardiogram Treatment Visit 5 Post Dose	398.3 milliseconds Standard Deviation 41.02	—

PRIMARY outcome

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

Population: fewer patients at later visits due to attrition

QTc interval reported in milliseconds (msecs)

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
QTc Interval Assessed by 12-Lead Electrocardiogram Baseline	428.8 milliseconds Standard Deviation 24.92	—
QTc Interval Assessed by 12-Lead Electrocardiogram Treatment Visit 2	431.5 milliseconds Standard Deviation 24.49	—
QTc Interval Assessed by 12-Lead Electrocardiogram Treatment Visit 5 Pre Dose	430.3 milliseconds Standard Deviation 21.10	—
QTc Interval Assessed by 12-Lead Electrocardiogram Treatment Visit 5 Post Dose	430.3 milliseconds Standard Deviation 21.10	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
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 Interval 23.7 to 113.9	—
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 Interval 19.0 to 102.8	—
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 Interval 4.2 to 13.0	—
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 Interval 2.8 to 15.9	—

SECONDARY outcome

Timeframe: 7 weeks

Population: 36 patients with evaluable PET-biopsy pairs at baseline 33 patients with evaluable PET-biopsy pairs at on treatment

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)

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 Participants 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)	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
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	—
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	—
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	—
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 5.0	—
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	—
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	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=69 lesions 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)	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
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	—
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	—
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	—
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	—
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	—
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	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Correlation of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) uptake with clinical outcomes

Outcome measures

Outcome data not reported

Adverse Events

⁸⁹Zr-Df-IAB22M2C Infusion

Serious events: 11 serious events

Other events: 40 other events

Deaths: 3 deaths

Serious adverse events

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 participants at risk A dose of 3 mCi (±20%) of ⁸⁹Zr-Df-IAB22M2C between 0.5 mg to 1.5 mg of API will be administered intravenously over 5-10 minutes, within one week prior to the onset of immunotherapy, and 5 to 6 weeks after start of IOT. ⁸⁹Zr-Df-IAB22M2C: ⁸⁹Zr-Df-IAB22M2C CD8 T cell tracer for Positron Emission Tomography (PET)
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	3.8% 2/52 • Number of events 2 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.9% 1/52 • Number of events 2 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	1.9% 1/52 • Number of events 2 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Gastrointestinal disorders Diarrhoea	1.9% 1/52 • Number of events 1 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Gastrointestinal disorders Large intestinal obstruction	1.9% 1/52 • Number of events 1 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Gastrointestinal disorders Rectal haemorrhage	1.9% 1/52 • Number of events 1 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Gastrointestinal disorders Small intestinal obstruction	1.9% 1/52 • Number of events 1 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Infections and infestations Pneumonia	1.9% 1/52 • Number of events 1 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Infections and infestations Urinary tract infection	1.9% 1/52 • Number of events 1 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Injury, poisoning and procedural complications Compression fracture	1.9% 1/52 • Number of events 1 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Injury, poisoning and procedural complications Post procedural haemorrhage	1.9% 1/52 • Number of events 1 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	3.8% 2/52 • Number of events 2 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Blood and lymphatic system disorders Thrombocytopenia	1.9% 1/52 • Number of events 1 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Cardiac disorders Intracardiac thrombus	1.9% 1/52 • Number of events 1 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
General disorders Asthenia	1.9% 1/52 • Number of events 1 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Hepatobiliary disorders Cholecystitis acute	1.9% 1/52 • Number of events 1 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Investigations Alanine aminotransferase increased	1.9% 1/52 • Number of events 1 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Metabolism and nutrition disorders Acidosis	1.9% 1/52 • Number of events 1 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Musculoskeletal and connective tissue disorders Muscular weakness	1.9% 1/52 • Number of events 1 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Nervous system disorders Cerebrovascular accident	1.9% 1/52 • Number of events 1 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.

Other adverse events

Measure	⁸⁹Zr-Df-IAB22M2C Infusion n=52 participants at risk A dose of 3 mCi (±20%) of ⁸⁹Zr-Df-IAB22M2C between 0.5 mg to 1.5 mg of API will be administered intravenously over 5-10 minutes, within one week prior to the onset of immunotherapy, and 5 to 6 weeks after start of IOT. ⁸⁹Zr-Df-IAB22M2C: ⁸⁹Zr-Df-IAB22M2C CD8 T cell tracer for Positron Emission Tomography (PET)
Gastrointestinal disorders Constipation	15.4% 8/52 • Number of events 8 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Gastrointestinal disorders Nausia	13.5% 7/52 • Number of events 11 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Gastrointestinal disorders Diarrhoea	11.5% 6/52 • Number of events 13 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Gastrointestinal disorders Vomiting	11.5% 6/52 • Number of events 8 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Gastrointestinal disorders Abdominal pain	9.6% 5/52 • Number of events 5 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Gastrointestinal disorders Dry mouth	5.8% 3/52 • Number of events 4 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Gastrointestinal disorders Abdominal distension	3.8% 2/52 • Number of events 2 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
General disorders Fatigue	15.4% 8/52 • Number of events 9 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
General disorders Pyrexia	7.7% 4/52 • Number of events 5 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
General disorders Oedema peripheral	5.8% 3/52 • Number of events 5 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
General disorders Chills	3.8% 2/52 • Number of events 2 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
General disorders Pain	3.8% 2/52 • Number of events 2 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Metabolism and nutrition disorders Hypokalaemia	11.5% 6/52 • Number of events 9 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Metabolism and nutrition disorders Decreased appetite	11.5% 6/52 • Number of events 7 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Metabolism and nutrition disorders Dehydration	5.8% 3/52 • Number of events 3 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Metabolism and nutrition disorders Hyperglycaemia	5.8% 3/52 • Number of events 3 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Metabolism and nutrition disorders Hypomansesaemia	3.8% 2/52 • Number of events 3 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Metabolism and nutrition disorders Hyperkalemia	3.8% 2/52 • Number of events 2 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Metabolism and nutrition disorders Hyponatraemia	3.8% 2/52 • Number of events 2 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Respiratory, thoracic and mediastinal disorders Cough	11.5% 6/52 • Number of events 6 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.8% 3/52 • Number of events 3 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	3.8% 2/52 • Number of events 2 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	3.8% 2/52 • Number of events 2 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.8% 2/52 • Number of events 2 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Skin and subcutaneous tissue disorders Pruritis	15.4% 8/52 • Number of events 9 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Skin and subcutaneous tissue disorders Rash	7.7% 4/52 • Number of events 5 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Skin and subcutaneous tissue disorders Rash maculo-papular	3.8% 2/52 • Number of events 2 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Musculoskeletal and connective tissue disorders Pain in extremity	9.6% 5/52 • Number of events 7 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Musculoskeletal and connective tissue disorders Arthralgia	5.8% 3/52 • Number of events 3 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Musculoskeletal and connective tissue disorders Muscular weakness	3.8% 2/52 • Number of events 3 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.8% 2/52 • Number of events 3 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Investigations Blood creatinine increased	5.8% 3/52 • Number of events 5 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Investigations Aspartate aminotransferase increased	3.8% 2/52 • Number of events 4 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Investigations Alanine aminotransferase increased	3.8% 2/52 • Number of events 3 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Investigations Gamma-glutamyltransferase increased	3.8% 2/52 • Number of events 3 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Investigations Weight decreased	3.8% 2/52 • Number of events 3 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Investigations Lymphocyte count decreased	3.8% 2/52 • Number of events 2 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Vascular disorders Hypertension	11.5% 6/52 • Number of events 34 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Vascular disorders Hypotension	3.8% 2/52 • Number of events 2 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Injury, poisoning and procedural complications Fall	7.7% 4/52 • Number of events 6 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Injury, poisoning and procedural complications Procedural pain	5.8% 3/52 • Number of events 3 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Injury, poisoning and procedural complications Contusion	3.8% 2/52 • Number of events 2 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Cardiac disorders Sinus bradycardia	7.7% 4/52 • Number of events 5 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Psychiatric disorders Anxiety	5.8% 3/52 • Number of events 5 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Psychiatric disorders Insomnia	5.8% 3/52 • Number of events 3 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Nervous system disorders Headache	3.8% 2/52 • Number of events 2 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Blood and lymphatic system disorders Anaemia	5.8% 3/52 • Number of events 7 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Blood and lymphatic system disorders Thrompocytopenia	5.8% 3/52 • Number of events 3 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	3.8% 2/52 • Number of events 3 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	3.8% 2/52 • Number of events 2 • 3 months AEs defined as any unfavorable or unintended sign, symptom, or disease that occurred or was reported by the patient, or a worsening of a pre-existing condition. Clinically significant lab results are regarded as AEs. Please note that most TEAEs are attributable to standard of care treatments rather than the study IP.

Additional Information

Director, Regulatory Affairs

ImaginAb

Phone: : +1.310.730.5869

Email: ethomas@imaginab.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place