Kura Oncology’s FIT-001 Phase I dose-escalation trial of KO-2806, a farnesyl transferase inhibitor (FTI) for the treatment of advanced solid tumours, has commenced with the dosing of the first patient.
FIT-001 is a first-in-human, multicentre, open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of KO-2806 when administered as monotherapy and in combination with targeted therapies.
Concurrent with the monotherapy dose escalation, the company plans to evaluate KO-2806 in dose-escalation combination cohorts with other targeted therapies, beginning in KRASG12C-mutant non-small cell lung cancer (NSCLC) and clear cell renal cell carcinoma (ccRCC).
Troy Wilson, President and Chief Executive Officer of Kura Oncology, said: “With the success of targeted therapies such as KRASG12C inhibitors, tyrosine kinase inhibitors and EGFR inhibitors, there is now considerable focus on the development of companion therapeutics that have potential to drive enhanced antitumor activity and address mechanisms of innate and adaptive resistance. We will focus the development of KO-2806 initially in combinations in the areas of lung cancer and renal cell carcinomas and, if successful, we believe KO-2806 could become the ideal combination partner for a wide range of targeted therapies.”
KO-2806 is a next-generation inhibitor of farnesyl transferase designed to improve upon potency, pharmacokinetic and physicochemical properties of earlier FTI drug candidates. Kura has promising preclinical data supporting the rationale for combining KO-2806 with distinct classes of targeted therapies, including tyrosine kinase inhibitors, KRASG12C inhibitors and KRASG12D inhibitors.