Boston Biomedical has dosed the first patient in a Phase l clinical trial to test the safety and pharmacokinetic of intravenously administered DSP-0509 to treat adults with advanced solid tumours.
The open-label, multicentre trial intends to enrol 44 patients with advanced solid tumours that are refractory to standard treatment.
It will comprise two stages; an initial dose-escalation phase that will use a 3+3 design to establish the maximum tolerated dose, and a dose-expansion phase in up to 14 additional subjects.
As part of the trial, patients will initially receive an intravenous dose of DSP-0509 once a week in induction phase, and once every two weeks in a maintenance phase.
Based on the success of these doses, Boston Biomedical plans to continue treatment until disease progression.
The trial’s primary goals are maximum tolerated dose, identification of Recommended Phase 2 Dose (RP2D), as well as incidence of adverse events (AEs), serious AEs (SAEs), and immune-related AEs (irAEs).
Its secondary goals include pharmacokinetics, objective response rate (ORR), duration of response (DoR), progression-free survival (PFS) and others.
The trial is currently being carried out at various sites in the US.
Boston Biomedical CEO Patricia Andrews said: “We are looking forward to exploring the safety and activity of DSP-0509 and understanding more about its potential in treating cancer.”
DSP-0509 is currently being studied as a synthetic Toll-like receptor (TLR) 7 agonist.
In preclinical settings, DSP-0509 showed its potential to promote the cytokine induction and cytotoxic T lymphocyte (CTL) activation through agonistic effect of TLR 7 expressed in plasmacytoid dendritic cells.