A CLINICAL TRIAL TO LEARN ABOUT THE SAFETY AND EFFECTS OF STX-241, A NEW ORAL ANTICANCER DRUG FOR THE TREATMENT OF PATIENTS WITH ADVANCED LUNG CANCER- “STX-241 FIH STUDY“

The objective of this trial is to evaluate the safety, the tolerance and the activity of an experimental treatment PFL-241/STX-241 (called STX-241) in patients with advanced non-small cell lung cancer (large local or distant spread of their lung tumor) This is the first time that this treatment STX-241 is tested in humans. The clinical trial has 3 successive and separate parts: 

• The Part 1 (Dose Escalation and Backfilling components or Phase Ia) with two components: 
  - Dose Escalation component will determine the highest dose that can be safely administered to participants.
  - Backfilling component will help to identify at least two safe doses with preliminary activity of STX-241 that will be tested in Part 2 of the study.
• The Part 2 (Dose Optimization or Phase Ib) will determine the best dose of STX-241 to be used further in the Part 3.
• The Part 3 (Expansion Part or Phase II) will be added to the protocol once sufficient data are available to design this part.