A Phase I/II Study of BAY 1895344 (Elimusertib) in Pediatric Patients with Persistent or Recurrent Solid Tumors

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Full Title

A Phase 1/ 2 Study of BAY 1895344 (elimusertib, IND#152153, NSC#810486) in Pediatric Patients with Relapsed or Refractory Solid Tumors (PEPN2112) (CIRB)

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug BAY 1895344 (elimusertib) in children, adolescents, and young adults with solid tumors that have come back or continued to grow despite prior treatment. Elimusertib may stop the growth of tumor cells by blocking ATR, an enzyme needed to repair DNA. It is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have Ewing sarcoma, alveolar rhabdomyosarcoma, or another solid tumor, including lymphoma, with certain genetic changes in tumor cells. Patients with tumors arising from the brain or spinal cord are not eligible for this study.
  • Patients’ cancers must have come back or kept growing despite treatment.
  • The serious side effects of previous treatments must go away before receiving elimusertib.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 1-30 years.

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

Protocol

21-494

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators