Full Title
Phase 1/2 Study of TPX-0005 (Repotrectinib) in Combination with Chemotherapy in Pediatric and Young Adult Subjects with Advanced or Metastatic Solid Tumors and Primary Central Nervous System TumorsPurpose
The purpose of this study is to assess the safety and effectiveness of the investigational drug repotrectinib in children and young adults with solid tumors that have continued to grow or spread despite treatment. Repotrectinib works by targeting and blocking certain proteins that play a role in cancer growth. Some of these proteins are controlled by the ALK, ROS1, NTRK1, NTRK2, and NTRK3 genes. Researchers also think that combining repotrectinib with the chemotherapy drugs irinotecan and temozolomide may make the treatment more effective.
There are two parts to this study. In the first part, researchers will find the highest dose of repotrectinib that can be given safely with irinotecan and temozolomide. In the second part, the highest safe dose will continue to be assessed in combination with irinotecan and temozolomide to see if this drug combination is effective. Repotrectinib and temozolomide are taken orally (by mouth) and irinotecan is given intravenously (by vein).