Phase I Study of AN9025 Oral Treatment for Advanced or Metastatic Solid Tumors With RAS Mutations Evaluating Safety, Tolerability, and Anti-Tumor Effects

What this Trial Is About

This research aims to evaluate the safety and tolerability of AN9025, an oral pan-RAS inhibitor, in adults with advanced or metastatic solid tumors that have specific RAS genetic mutations. The study seeks to identify safe dose levels for future testing and to understand the medical effects participants may experience while taking AN9025. It involves participants with cancers such as pancreatic, colorectal, lung, melanoma, and biliary tract cancers that have progressed after standard treatments. The study has three parts Dose-Escalation, Food Effect Assessment, and Dose-Expansion. In Dose-Escalation, participants receive increasing doses of AN9025 once daily or once weekly in 21-day cycles to find the maximum tolerated dose. The Food Effect Assessment studies how eating affects the drugs levels in the body. Dose-Expansion evaluates AN9025s activity and safety in specific tumor types at selected dose levels. Participants take AN9025 capsules orally throughout the study. Participants will visit the clinic multiple times during the first 21 days for tests, blood draws, and possibly tumor tissue samples. Afterwards, clinic visits occur every 21 days for ongoing monitoring and assessments. After stopping treatment, participants return for follow-ups at 14 and 30 days and are contacted every three months to check on their health status. Researchers will measure dose-limiting toxicities, tumor responses, drug levels in blood, and participant survival over about one year.

Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations