Phase 1 Study of KO-2806 as Single Agent and in Combination for Adults with Advanced Solid Tumors Including RAS-Altered Tumors, NSCLC, CRC, PDAC, and Renal Cell Carcinoma

What this Trial Is About

Researchers are evaluating KO-2806, a farnesyltransferase inhibitor FTI, in adult patients with advanced solid tumors. This first-in-human study is designed to assess KO-2806 as a monotherapy and in combination with other treatments. The trial focuses on patients with specific genetic tumor alterations such as HRAS, KRAS, and NRAS mutations or amplifications, across various solid tumor types including lung, colorectal, pancreatic, and renal cancers. The study includes multiple treatment groups KO-2806 alone for HRAS-altered tumors combinations with cabozantinib or adagrasib for advanced or metastatic renal cell carcinoma RCC, non-small cell lung cancer NSCLC, colorectal cancer CRC, and pancreatic ductal adenocarcinoma PDAC. Treatments are administered orally, with dose escalation and expansion phases to evaluate safety, dosing, and preliminary antitumor activity. Participants will undergo regular assessments including evaluation of adverse events, dose-limiting toxicities, and tumor response using RECIST v1.1 criteria. Pharmacokinetics, pharmacodynamics, and other laboratory tests will be conducted during treatment cycles, which last 28 days each. The trial includes monitoring for up to 24 months of treatment and survival follow-up up to 37 months, aiming to gather detailed safety and efficacy data for KO-2806 in this patient population.

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors