In short
TD001 is an investigational protein-based substance being studied for metastatic castration-resistant prostate cancer. It is given by intravenous infusion and has no marketing authorisation, meaning it is not yet approved as a medicine. The only registered trial is a Phase 1/2 first-in-human study with 180 planned participants, currently authorised but not yet recruiting.
Key points
- TD001 is an investigational protein-based substance with no marketing authorisation.
- It is being studied in metastatic castration-resistant prostate cancer.
- The only registered trial is a Phase 1/2 first-in-human study.
- The trial plans to enrol 180 participants.
- The study is currently authorised but not yet recruiting.
- TD001 is given as a solution for infusion into a vein.
What is TD001?
TD001 is an investigational protein-based substance developed by T.O.A.D. ONCOLOGY SA. It is classified in the therapeutic area of neoplasms, meaning it is being developed for cancer treatment. The substance has no marketing authorisation in the product records, so it is not yet an approved medicine. TD001 is the only name under which the substance appears in the registry.
How does TD001 work?
The registered trial describes TD001 as a drug intended to treat patients with metastatic prostate cancer that expresses the PSMA protein. PSMA stands for prostate-specific membrane antigen, a protein found on the surface of prostate cancer cells. The trial title indicates that TD001 targets PSMA-expressing tumours, but the registry does not provide further details about its exact mechanism of action.
Which conditions is it studied for?
- Metastatic castration-resistant prostate cancer — a form of prostate cancer that has spread to other parts of the body and no longer responds to treatments that lower testosterone.
How is TD001 given?
TD001 is prepared as a solution for infusion and is given intravenously, meaning it is delivered directly into a vein. The trial records do not specify the dose or how often the infusion is given.
What do the clinical trials show?
One trial is registered for TD001: a Phase 1/2 first-in-human study in metastatic castration-resistant prostate cancer. The trial is currently authorised, meaning it has received regulatory approval to begin, but it is not yet recruiting participants. The study plans to enrol 180 participants.
The trial has two parts. The dose escalation part aims to determine the maximum tolerated dose (MTD) and the recommended Phase 2 doses (RP2Ds) of different administration schedules of TD001. The dose expansion part aims to evaluate the safety and tolerability of the recommended Phase 2 doses.
The main things the trial measures are the incidence and severity of dose-limiting toxicities (DLTs) during the first treatment cycle in the dose escalation part, as well as the incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs), laboratory parameters, and treatment discontinuations or modifications due to adverse events. A dose-limiting toxicity is a side effect severe enough to prevent increasing the dose further.
What side effects are known?
The registry does not report any side effects from completed studies, because the trial has not yet started recruiting participants. The trial is designed to measure adverse events and serious adverse events as primary outcomes, so safety information will become available once the study is underway.