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Kura Oncology Begins Phase I Trial of KO-2806 in RAS-Altered Cancers

NEW YORK – Kura Oncology said on Wednesday that it has begun treating patients in a Phase I trial of its farnesyl transferase inhibitor, KO-2806, plus Exelixis' tyrosine kinase inhibitor Cabometyx (cabozantinib) in renal cell carcinoma.

Researchers have dosed the first patient in the clear cell renal cell carcinoma combination treatment cohort of the FIT-001 trial. The other arm of the study will evaluate KO-2806 as a monotherapy in patients with HRAS-mutant tumors, KRAS-, NRAS-, or HRAS-mutant non-small cell lung or colorectal cancer, and KRAS-mutant pancreatic cancer.

Kura, based in San Diego, expects to begin dosing another combination cohort in the FIT-001 trial in Q2, evaluating KO-2806 plus Mirati Therapeutics' Krazati (adagrasib) in KRAS G12C-mutant NSCLC. In preclinical studies, researchers have shown that KO-2806 could prevent adaptive resistance to other targeted therapies, including Cabometyx, Krazati, and PI3K inhibitors.

"This innovative, first-in-human trial builds upon our leadership position in the development of [farnesyl transferase inhibitors]," Stephen Dale, chief medical officer of Kura Oncology, said in a statement, adding that it "has the potential to address mechanisms of innate and adaptive resistance of targeted therapies, while driving tumor regressions and enhancing both duration and depth of antitumor response in preclinical models of clear cell renal cell carcinoma."

KO-2806 is Kura's second farnesyl transferase inhibitor to enter the clinic. Its first, tipifarnib, is being studied in a Phase I/II trial with Novartis' PI3K inhibitor Piqray (alpelisib) in HRAS- or PIK3CA-dependent head and neck cancer.