This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-2806, a farnesyltransferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.
At least 18 years of age.
Histologically or cytologically confirmed advanced solid tumors
Arm #1 (KO-2806 monotherapy): Patients who have progressed on, or are refractory to, standard of care (SOC) treatments with advanced solid tumors, specifically: HRAS-mutant and/or amplified tumors (any solid tumor type); HRAS overexpression (only for HNSCC tumors); KRAS and/or NRAS, and/or HRAS-mutant and/or amplified NSCLC or CRC; KRAS-mutant and/or amplified PDAC
Arm #2 (Combination): Patients who have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic RCC with predominantly clear cell subtype; non-clear cell RCC patients who are either treatment-naïve or have received any prior systemic treatment for locally advanced and metastatic RCC.
Any use of anticancer therapy within 14 days or 5 half-lives (whichever is shorter) of Cycle 1 Day 1.
Prior treatment with an FTI or HRAS inhibitor.
Major surgery, other than local procedures, within 28 days prior to Cycle 1 Day 1, without complete recovery.
Spinal cord compression, leptomeningeal disease, or clinically active CNS metastases.
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Treatment groupsSee each treatment group below.
Kura Oncology, Inc.
Lead sponsor
Mirati Therapeutics Inc.
Collaborator