Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [89Zr]Df-IAB2M
Df-IAB2M · 2 trials · 2 indications
To assess the safety of a single dose of of \[89Zr\]Df-IAB2M
| Arm | Type | Description |
|---|---|---|
| [89Zr]Df-IAB2M | EXPERIMENTAL | A single intravenous infusion of 2.5 mCi of \[89Zr\]Df-IAB2M in a mass dose of 10 mg. |
| Name | Type | Description |
|---|---|---|
| [89Zr]Df-IAB2M | RADIATION | - |
Inclusion Criteria: Patients must meet ALL criteria listed below for entry: * Age ≥ 18 years * Signed, written IRB-approved informed consent * Patients newly diagnosed with biopsy-proven prostate cancer, thought to be a candidate for prostatectomy after standard diagnostic evaluation (e.g. chest x...
Top 20 of 55 competitors
Df-IAB2M is an investigational monoclonal antibody imaging agent labeled with zirconium-89, developed by Telix Pharmaceuticals Limited for prostate cancer. It is used in PET imaging to detect prostate cancer, including metastatic prostate cancer, and has been studied in men 18 years and older.
Df-IAB2M is used for PET imaging in prostate cancer, including metastatic prostate cancer. It has been evaluated for detecting prostate cancer before prostatectomy and for imaging metastatic disease. It is an investigational agent and is not approved for clinical use.
Df-IAB2M is being developed by Telix Pharmaceuticals Limited, which trades under the ticker TLX. The company is the sponsor of the clinical trials evaluating this imaging agent in prostate cancer.
Df-IAB2M is in Phase 1 development. It has been studied in a Phase 1/2A trial in metastatic prostate cancer and a Phase 2 comparison trial in prostate cancer before prostatectomy. It is investigational and has not been approved by the FDA.
Df-IAB2M has been studied in two completed trials: NCT01923727, a Phase 1/2A PET imaging study in metastatic prostate cancer with 38 participants, and NCT02349022, a Phase 2 comparison of PET imaging with [89Zr]-Df-IAB2M and [111In]-capromab pendetide in prostate cancer before prostatectomy with 19 participants.
Yes, Df-IAB2M and [89Zr]Df-IAB2M refer to the same agent. The [89Zr] prefix indicates the antibody is labeled with zirconium-89 for PET imaging. Both names appear in the clinical trial literature for this Telix Pharmaceuticals imaging agent.