A Phase I/II Study of Repotrectinib in Combination with Chemotherapy in Children and Young Adults with Advanced Solid Tumors

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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 Tumors

Purpose

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).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a solid tumor that has continued to grow or spread despite treatment.
  • Patients should recover from the serious side effects of prior therapies before receiving the study treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 1-25 years.

For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.

Protocol

21-156

Phase

I/II

Investigator

O'Donohue, Tara, MD

Co-Investigators