Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zr-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 small molecule being developed for use in positron-emission tomography (PET) imaging. It is being studied as a CD8 PET tracer for PET/CT imaging in patients with metastatic solid tumors, according to a completed Phase 2 clinical trial.
⁸⁹Zr-Df-IAB22M2C targets CD8, a protein found on the surface of cytotoxic T cells. By binding to CD8, the tracer is designed to enable PET imaging of the immune response within tumors, potentially allowing visualization of CD8-positive cells in the tumor microenvironment.
⁸⁹Zr-Df-IAB22M2C is being developed by Telix Pharmaceuticals Limited, a biopharmaceutical company listed on the Australian Securities Exchange under the ticker TLX. The company is focused on the development of diagnostic and therapeutic radiopharmaceuticals.
⁸⁹Zr-Df-IAB22M2C is in Phase 2 clinical development. It is an investigational agent and has not been approved by regulatory authorities. A Phase 2 trial evaluating the tracer in patients with metastatic solid tumors has been completed.
⁸⁹Zr-Df-IAB22M2C has been studied in one completed Phase 2 clinical trial, identified as NCT03802321. The trial, titled "⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for PET/CT in Patients With Metastatic Solid Tumors," enrolled 52 participants in the United States.
⁸⁹Zr-Df-IAB22M2C is also known as a CD8 PET tracer. The drug name ⁸⁹Zr-Df-IAB22M2C refers to the specific radiolabeled compound, while "CD8 PET tracer" describes its function as an imaging agent that targets CD8 for positron-emission tomography.