A Phase I Study of Copanlisib in Children and Adolescents with Recurrent or Persistent Solid Tumors or Lymphoma


Full Title

A Non-Randomized, Open-Label, Multi-Center, Phase I/II Study of PI3K Inhibitor Copanlisib in Pediatric Patients with Relapsed/Refractory Solid Tumors or Lymphoma


The purpose of this study is to find the highest dose of the drug copanlisib that can be used safely in children and adolescents with solid tumors or lymphoma that came back or continued to grow after prior therapy. Copanlisib works by targeting an enzyme called PI3K, which drives the growth of some cancers. It is approved by the FDA to treat recurrent follicular lymphoma in adults; its use in this study is considered investigational. Copanlisib is given intravenously (by vein).


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

  • Patients must have a solid tumor (including neuroblastoma, osteosarcoma, Ewing sarcoma, and rhabdomyosarcoma), Hodgkin lymphoma, or non-Hodgkin lymphoma that has come back or continued to grow despite standard treatment or for which no standard treatment is available.
  • At least 4 weeks must pass between the completion of prior therapies and receipt of copanlisib.
  • 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 6 months to 21 years.

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