In short
Terbium (161TB) zadavotide guraxetan is an investigational radiopharmaceutical being studied in prostate cancer. It is currently being tested in a Phase 1 clinical trial in patients with very high-risk prostate cancer before surgery. The trial plans to enroll 18 participants to determine dose-limiting toxicities and a recommended Phase 2 dose.
Key points
- Terbium (161TB) zadavotide guraxetan is an investigational radiopharmaceutical, not yet an authorised medicine.
- It is being studied in a Phase 1 clinical trial in patients with very high-risk prostate cancer.
- The trial is authorised and plans to enroll 18 participants.
- The medicine is given as an intravenous injection at a dose of 11.1 GBq.
- The main goal is to find dose-limiting toxicities and a recommended Phase 2 dose.
- The treatment is given before surgery (neoadjuvant therapy) in patients eligible for radical prostatectomy.
What is terbium (161TB) zadavotide guraxetan?
Terbium (161TB) zadavotide guraxetan is an investigational radiopharmaceutical, a type of medicine that combines a radioactive substance with a targeting molecule. The full name is Terbium (161TB) zadavotide guraxetan, also referred to as TRP-001 in the clinical trial protocol. It is not yet an authorised medicine; it is being investigated in clinical trials to understand its safety and dosing in people with cancer. The substance belongs to the class of radiolabelled compounds used experimentally to deliver radiation to cancer cells.
How does terbium (161TB) zadavotide guraxetan work?
The exact mechanism of action of terbium (161TB) zadavotide guraxetan is not described in detail in the available trial registry data. As a radiopharmaceutical, it is designed to deliver the radioactive isotope terbium-161 to target tissues. The trial record does not specify the molecular target of the zadavotide guraxetan component. The Phase 1 study focuses on establishing the safety profile and dosing rather than confirming how the drug works in the body.
Which conditions is terbium (161TB) zadavotide guraxetan studied for?
- Very high-risk prostate cancer — the trial enrolls patients with this aggressive form of prostate cancer who are eligible for surgery (radical prostatectomy with extended pelvic lymph node dissection).
How is terbium (161TB) zadavotide guraxetan given?
Terbium (161TB) zadavotide guraxetan is given as an intravenous injection. In the Phase 1 trial, the planned dose is 11.1 gigabecquerels (GBq), a unit used to measure radioactivity. The treatment is administered before surgery, as a neoadjuvant therapy, meaning it is given to shrink or treat the cancer before the planned operation.
What do the clinical trials show?
There is one registered clinical trial of terbium (161TB) zadavotide guraxetan in the EU Clinical Trials Information System. It is a Phase 1 study, authorised but not yet reporting results, with a planned enrollment of 18 participants. The study is interventional and is being conducted in patients with very high-risk prostate cancer who are eligible for standard radical prostatectomy with extended pelvic lymph node dissection.
The primary outcome of the trial is the incidence of dose-limiting toxicities (DLTs) after the first treatment administration, during a defined DLT evaluation period. The study aims to determine the maximum tolerated dose (MTD) and the recommended dose for a Phase 2 study (RP2D) of TRP-001 as neoadjuvant monotherapy. No efficacy results are available yet, as the trial is in its early phase and results have not been published in the registry.
What side effects are known?
The available registry data does not include a list of side effects for terbium (161TB) zadavotide guraxetan. The Phase 1 trial is specifically designed to identify dose-limiting toxicities, which are side effects severe enough to prevent increasing the dose. These will be reported once the study has collected and analysed its data.