Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03802123 | ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for PET/CT in Patients With Metastatic Solid Tumors | PHASE2 | COMPLETED | 52 | — | — | Dec 18, 2018 | Jul 18, 2022 | Jul 9, 2024 | 15 | United States |
Analyze ⁸⁹Zr-Df-IAB22M2C uptake in biopsied tumors as determined by SUV-based quantitative measures (SUVmax, SUVpeak, SUVmean, CD8 tumor volume, and tumor:reference tissue ratio) with CD8+ cell measurement determined by IHC from biopsy samples.
Number of participants who experienced any treatment emergent adverse events
Number of participants with reported signs or symptoms of infusion reactions
WBC absolute counts
hematocrit (%) laboratory values
hemoglobin (g/dL) laboratory values compared with baseline results.
platelet count laboratory values compared with baseline results.
WBC count laboratory values compared with baseline results.
RBC count laboratory values compared with baseline results.
blood glucose (mg/dL) laboratory values compared with baseline results.
chloride laboratory values compared with baseline results.
Potassium laboratory values compared with baseline results.
sodium laboratory values compared with baseline results.
serum creatinine (mg/dL) laboratory values compared with baseline results.
GGT (U/L) laboratory values compared with baseline results.
BUN (mg/dL) laboratory values compared with baseline results.
LDH (U/L) laboratory values compared with baseline results.
Total bilirubin (mg/dL) laboratory values compared with baseline results.
Change/shifts in ALP (U/L) laboratory values compared with baseline results.
Change/shifts in ALT (U/L) laboratory values compared with baseline results.
Change/shifts in AST (U/L) laboratory values compared with baseline results.
PR interval reported in milliseconds (msecs)
Changes/shifts in heart rate
Changes/shifts in respiration rate
Changes/shifts in temperature
QRS Interval reported in milliseconds (msec)
QT interval reported in milliseconds (msec)
QTc interval reported in milliseconds (msecs)
| Arm | Type | Description |
|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C Infusion | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| ⁸⁹Zr-Df-IAB22M2C | DRUG | ⁸⁹Zr-Df-IAB22M2C CD8 T cell tracer for Positron Emission Tomography (PET) |
Inclusion Criteria: Participants will be eligible for enrollment in the study only if they meet ALL of the following criteria: 1. 1\. Patients with advanced or metastatic Melanoma, Non-Small Cell Lung Cancer, Renal Cell Carcinoma or Squamous Cell Carcinoma of the Head and Neck with at least one no...