Pierre Fabre STX-241 (SILVER)

Thoracic tumors
Non-small cell lung cancer (NSCLC)
other systemic therapies
EGFR weitere Mutationen
This trial is an international, multicenter, open-label Phase I/II first-in-human study assessing the safety and efficacy of STX-241 in participants with EGFR-mutated NSCLC. The primary objectives are to establish the maximum tolerated dose (MTD) and to evaluate the objective response rate (ORR) per RECIST 1.1. Eligible participants are adults with locally advanced or metastatic non-small cell lung cancer who have demonstrated resistance to prior EGFR tyrosine kinase inhibitor (TKI) therapy. Molecular eligibility is confirmed during screening to identify specific EGFR mutations. Participants are enrolled in dose-escalation and dose-expansion cohorts to receive STX-241. Key secondary endpoints include pharmacokinetics (PK), duration of response (DOR), and progression-free survival (PFS).
This Phase I/II clinical trial evaluates the new investigational drug STX-241 in patients with a specific type of lung cancer. The study is designed for individuals with locally advanced or metastatic non-small cell lung cancer (NSCLC) driven by mutations in the EGFR gene. It focuses on patients whose cancer has become resistant to previous standard treatments known as tyrosine kinase inhibitors (TKIs). The primary goal of the study is to assess the safety of STX-241 and to determine the most appropriate dose for patients. Researchers are also monitoring how effectively the drug can shrink or control the tumor. Participants will receive STX-241 in an open-label setting, meaning both the doctors and the patients know which medication is being administered.