A Phase 1 Study to Assess Safety and Effectiveness of XL309 Alone and with Olaparib in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating XL309 previously ISM3091, alone and in combination with olaparib, in participants with advanced solid tumors. This first-in-human, multicenter, open-label Phase I trial aims to assess the safety, tolerability, preliminary antitumor activity, as well as how the body processes and responds to XL309 in these patients. The study is sponsored by Exelixis and targets advanced cancers that have progressed despite standard treatments or have no current therapies available. The study includes a Dose Escalation Stage where participants receive increasing doses of XL309 alone or combined with olaparib. Following this, a Cohort Expansion Stage will further study the recommended dose in specific advanced solid tumor groups both as a single agent and in combination. Both drugs are given orally according to assigned schedules in sequential cohorts. The trial is non-randomized and open-label, meaning all participants know which treatment they are receiving. Participants will undergo safety monitoring for treatment-related adverse events, dose-limiting toxicities, and laboratory abnormalities over approximately 24 months. Researchers will also measure drug levels in the blood and tumor response rates. Eligibility includes adults with specific genetic alterations related to their cancer type, adequate organ function, and performance status. The study excludes those with recent anticancer treatments, untreated brain metastases, or certain health conditions. Participants may be followed for up to several years to evaluate safety and preliminary efficacy.

A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors