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 tumors
Principal Investigator: Tara O’Donohue, MD, of Memorial Sloan Kettering Cancer Center in New York, New York
Description: Researchers are conducting a phase 1/2 trial to assess the safety and efficacy of adding repotrectinib to irinotecan and temozolomide in children and young adults with advanced or metastatic solid tumors or primary central nervous system tumors.
In phase 1 of the trial, researchers will determine the maximum tolerated dose of repotrectinib. In phase 2, researchers will evaluate the efficacy of repotrectinib in combination with irinotecan and temozolomide.
The primary outcome measures are dose-limiting toxicities and the maximum tolerated dose.
To be eligible for this study, patients must be 1 to 25 years of age. They must have relapsed or refractory disease after receiving standard therapy. For a complete list of eligibility criteria, please see the reference.
This study is sponsored by Memorial Sloan Kettering Center.
ClinicalTrials.gov. A study of repotrectinib in combination with chemotherapy in children and young adults with solid tumor cancer. NCT05004116. Accessed June 16, 2022.