Kura Oncology, Inc. announced the clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for KO-2806, the Company's next-generation farnesyl transferase inhibitor (FTI), for the treatment of advanced solid tumors. The Company intends to evaluate safety, tolerability and preliminary antitumor activity of KO-2806 in a Phase 1 first-in-human study as a monotherapy and in combination with other targeted therapies. The Phase 1 first-in-human study is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of KO-2806 when administered as a monotherapy and in combination therapy in adult patients with advanced solid tumors.

Following completion of the dose escalation as a monotherapy, Kura plans to evaluate KO-2806 in dose escalation combination cohorts in advanced solid tumors. The Company expects to initiate the Phase 1 study in the third quarter of 2023.