Darlifarnib (KO-2806) and adagrasib in combination with cabozantinib - (FIT-001)

July 27, 2026: Kura Oncology, Inc. (NASDAQ: KURA) reported updated Phase 1a results from the ongoing FIT-001 trial (NCT06026410) evaluating darlifarnib plus cabozantinib in pre-treated, cabozantinib-naïve patients with locally advanced or metastatic clear cell renal cell carcinoma (ccRCC). Data were presented at the 2026 Kidney Cancer Research Summit (KCRS) in Boston.

In the cabozantinib-naïve ccRCC cohort (N=34), objective response rate ranged from 33% to 50% across darlifarnib dose levels; median progression-free survival was 13 months across pooled dose levels. Median duration of response was not estimable at most dose levels due to ongoing responses, and more than half of patients remained on treatment at the data cut-off.

Safety/tolerability in RCC patients (N=72) was described as manageable and generally consistent with the individual agents; neutropenia was managed with dose interruption/reduction and supportive care (allowed after the initial dose-limiting toxicity period).

A global randomized Phase 1b dose-optimization study is enrolling in the U.S. and E.U., comparing darlifarnib + cabozantinib vs cabozantinib alone to inform a recommended Phase 3 dose for a planned registrational study in 2028. An investor call was scheduled for July 27, 2026.