Phase 1 Study of the Safety and Best Dose of EXS74539 for Treating Select Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, and maximum tolerated dose of EXS74539 REC-4539 in adults with select solid tumors. This Phase 1, multicenter, open-label study focuses on participants whose disease has progressed, relapsed, or who have been intolerant to at least one prior standard systemic therapy. The trial includes various solid tumors such as small cell lung cancer, non-small cell lung cancer, prostate cancer, ovarian cancer, renal carcinoma, head and neck squamous cell carcinoma, hepatic cancer, gastric cancer, and triple-negative breast cancer. Participants receive EXS74539 orally as monotherapy in a dose-escalation format to determine the highest dose that can be tolerated. Treatment continues with monitoring for dose-limiting toxicities and adjustments as needed. The study is sequential and open-label, meaning all participants receive the active drug without placebo or blinding. This treatment period may last up to approximately three years depending on individual response and tolerance. During the study, participants undergo regular safety assessments including monitoring for adverse events and serious adverse events. Researchers also track pharmacokinetic measures such as drug concentration over time and evaluate tumor response using established criteria. Outcome measures include the number of dose interruptions, objective response rate, duration of response, progression-free survival, and overall survival. Participants are followed for up to three years to assess both safety and efficacy outcomes throughout and after treatment completion.

Dose Determining Study of EXS74539 (REC-4539) in Participants With Select Solid Tumors