A Phase II Study of Trastuzumab Deruxtecan (DS-8201A) in Adolescents and Young Adults with Recurrent HER2-Positive Osteosarcoma

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Full Title

A Phase 2 Study of DS-8201a (NSC#807708, IND#153036) in Adolescents, or Young Adults with Recurrent HER2+ Osteosarcoma (PEPN1924)(CIRB)

Purpose

This study is assessing the safety and effectiveness of the investigational drug trastuzumab deruxtecan (DS-8201A) in adolescents and young adults with osteosarcoma (bone cancer) that is positive for the HER2 protein and has come back after prior treatment. Trastuzumab deruxtecan includes an antibody (trastuzumab) linked to a chemotherapy drug (deruxtecan). Trastuzumab attaches to HER2-positive cancer cells in a targeted way and delivers deruxtecan to kill them. The treatment 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 recurrent osteosarcoma that is positive for HER2.
  • Patients should recover from the serious side effects of prior therapies before receiving trastuzumab deruxtecan.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients ages 12-39.

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

Protocol

21-147

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators