Jennifer Leddon, MD, PhD
Phase 1 - Solid Tumor
Phase 1
TRI611 in ALK Positive NSCLC
This is a Phase 1/2 study testing an oral drug called TRI-611 in adults with ALK-positive non-small cell lung cancer. The study has two parts. Part 1 finds the safest dose by giving increasing doses to small groups of participants. Part 2 tests how well the chosen dose works in three groups: people who had no prior ALK drugs, people who had several prior ALK drugs including lorlatinib and neladalkib, and people with intermediate prior treatment histories. Participants take TRI-611 daily as long as it helps and side effects are tolerable. They will visit the clinic about seven times in the first three months, then once at the start of each 28-day treatment cycle, and will keep a diary of doses. Main goals are to assess safety and side effects, pick a recommended dose, and measure tumor response and how long responses last. Some outcomes (like survival and duration of response) will be followed for up to about five years.
This study may be appropriate for those with: Metastatic Cancer