In the SAKK 65/16 trial, we will be investigating the safety and tolerability of TLD-1 (Talidox) in patients with advanced solid or metastatic tumors. We also want to define the optimum dose of TLD-1 for subsequent research projects. This will be first time that TLD-1 has been tested in humans in a clinical trial.
In addition to dose determination, this trial compares the plasma concentrations of TLD-1 with the plasma concentrations of Caelyx, a product that is already available on the market. To determine whether – and if so to what extent – TLD-1 is comparable with the authorized product Caelyx, the latter is administered in one cycle.
TLD-1 comprises the already successful chemotherapeutic agent doxorubicin, to which a novel kind of coating has been applied. This prevents it from being metabolized prematurely following administration, thus enabling the active substance to be transported to where it is needed in the body. A tumor might thus be attacked without damaging important and sensitive organs unnecessarily and side effects might be reduced.