Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
⁸⁹Zr-Df-IAB22M2C · 1 trial · 2 indications
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...
⁸⁹Zr-Df-IAB22M2C is an investigational positron emission tomography imaging agent developed by Telix Pharmaceuticals Limited. It is being studied for PET imaging in oncology, specifically in patients with metastatic solid tumors. It is a small molecule radiotracer and remains in clinical development.
⁸⁹Zr-Df-IAB22M2C is being studied for use in positron emission tomography imaging in oncology, including PET/CT imaging in patients with metastatic solid tumors. It is an investigational imaging agent and is not an approved product.
⁸⁹Zr-Df-IAB22M2C is developed by Telix Pharmaceuticals Limited, which trades under the ticker TLX. Telix is the sponsor of the clinical program evaluating this PET imaging agent in oncology.
⁸⁹Zr-Df-IAB22M2C is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The agent remains investigational and has not been approved for commercial use.
⁸⁹Zr-Df-IAB22M2C has been evaluated in one completed Phase 2 trial, NCT03802123, titled ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for PET/CT in Patients With Metastatic Solid Tumors. The trial enrolled 52 participants in the United States and studied adults aged 18 years and older.