A Phase 1 Study of Lurbinectedin in Children With Solid Tumors


Full Title

A Phase 1/2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Recommended Phase 2 Dose (RP2D), and Efficacy of Lurbinectedin Monotherapy in Pediatric Participants with Previously Treated Solid Tumors Followed by Expansion to Assess Efficacy and Safety in Pediatric and Young Adult Participants with Relapsed/Refractory Ewing Sarcoma


In this study, researchers are assessing the safety of the drug lurbinectedin in young people with solid tumors. In the first part, they will find the highest dose of lurbinectedin to use safely in children with solid tumors. If your child joins, this is the part of the study they will be in.

Later parts of the study will assess lurbinectedin in children and young adults with Ewing sarcoma. This cancer is a solid tumor that develops in bone or soft tissue.

Lurbinectedin is a type of drug called an alkylating agent. These medications target cancer cells and interfere with their DNA (genetic material) to slow or stop cell growth. Lurbinectedin is given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. Your child must:

  • Have a solid tumor cancer that keeps growing even after treatment.
  • Have no serious side effects from past treatments before they start taking lurbinectedin.
  • Be able to walk and do routine activities for more than half the time they are awake.
  • Be age 2-17.


For more information and to see if your child can join this study, please call 1-833-MSK-KIDS.




Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory


ClinicalTrials.gov ID