Phase Ia data for RNK08954, an oral KRAS G12D inhibitor developed by Ranok Therapeutics, show an overall objective response rate of 28% and a disease control rate of 86% across 36 evaluable patients with advanced solid tumors, with a notably higher response rate in the non-small cell lung cancer subgroup, according to results published in Cancer Discovery. The findings mark one of the earlier clinical readouts for a selective KRAS G12D-directed small molecule in this mutation class. Ranok operates out of Hangzhou, China, and Boston, Massachusetts.
In the NSCLC cohort, RNK08954 produced an ORR of 58.33% and a DCR of 100%, the company said. Across the full 36-patient evaluable population, the safety profile was characterized predominantly by Grade 1–2 gastrointestinal adverse events and decreased appetite. No dose-limiting toxicities were observed during dose escalation, and the study identified a recommended dose for expansion. The trial was conducted across multiple sites in China.
The Phase Ia study enrolled patients with advanced solid tumors harboring the KRAS G12D mutation, with the primary objectives of assessing safety, tolerability, and clinical activity, and determining the recommended dose for expansion. The evaluable population of 36 patients represents a subset of those enrolled; full enrollment figures were not disclosed in the company announcement. The data are preliminary, and the study was not designed as a randomized or controlled comparison. Cross-cohort interpretation is constrained by the single-arm design and the relatively small patient numbers within individual tumor-type subgroups.