CStone Pharmaceuticals has enrolled the first patient in a Phase l clinical trial of CS3006 for the treatment of patients with locally advanced or metastatic solid tumours.
The enrolled patient has already been dosed at the Linear Clinical Research Center in Australia.
The open-label, multiple-dose, dose-escalation and expansion trial aims to examine the safety, tolerability, pharmacokinetics (PK) and antitumour activities of CS3006 in the enrolled patients.
Scheduled to be completed by April 2020, the trial is expected to enrol a total of 60 adult patients.
The trial’s primary endpoint is the number of participants with adverse events from the day of the first dose of CS3006 to 30 days after the last dose.
In the trial’s experimental arm, the patients will receive CS3006 orally at specified doses on specified days.
In the dose-escalation stage, the dose levels will be increased following a modified 3+3 dose-escalation scheme, while the dose expansion part of the trial will see the patients receiving CS3006 at specified dose level(s).
CStone Pharmaceuticals chief medical officer Dr Jason Yang said: “CS3006 is a highly selective mitogen-activated protein kinase kinase (MEK) inhibitor.
“CS3006 demonstrated superior anti-tumour efficacy than the leading marketed MEK inhibitor in preclinical in vitro and in vivo studies, and the potential to combine with CStone's immuno-oncology pipeline products.
“This study comprises of a dose-escalation phase and an expansion phase that will determine the appropriate dosage for CS3006 in patients with solid tumours.”
CS3006 is CStone’s third experimental drug candidate to enter the first-in-human clinical trial in Australia, after the programmed death-1 (PD-1) inhibitor CS1003 and the cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) inhibitor CS1002.